Falcon® 50 mmx9 mm Not TC-treated in vitro Fertilization (IVF) ICSI/Biopsy Low Wall Dish (353655)
Non-Tissue Culture-treated Falcon Low Wall Dish can be utilized in the ICSI (IntraCytoplasmic Sperm Injection) procedure. This 50mm dish has many of the same features as the other IVF products except the dish is non-Tissue Culture-treated (nonwettable) for optimal media droplet consistency.
Well area: 18.3 cm², Height: 8.6mm
Pre-tested plasticware for in vitro fertilization (IVF)
CE marked to the Medical Device Directive 93/42/EEC
Manufactured in accordance with FDA Quality System Regulation
Nonembryotoxic, nonpyrogenic, noncytotoxic
Facilitated media droplet creation (Non TC-treated, cat. no. 353655 only)
Sterilized by gamma irradiation (10⁻⁶ SAL)
Flat-bottom for distortion-free optics
Packaged in peel-open, medical-style packaging
The Falcon low-wall dish has many of the same features as the other IVF products, except the dish is non-tissue culture (TC)-treated (non-wettable), for optimal media droplet consistency. The Falcon low-wall dish is ideal for ICSI and embryo biopsy, and makes the micromanipulation procedure easier to perform. This product is packaged in individually sealed blister compartments so one dish can be accessed at a time, and the remaining dishes are kept protected. Procedures requiring long term incubation are not recommended in the Falcon low-wall dish due to the tight lid fit, which results in low gas exchange rates.
Certified and Tested
Pre-tested Falcon® IVF products were the first plasticware available certified sterile, nonpyrogenic, noncytotoxic, and nonembryotoxic. These pre-tested products save you time and expense in complying with the College of American Pathologists and the American Society for Reproductive Medicine recommended standards for IVF labs.
Each lot of Falcon IVF product is subjected to a performance test for growth with a mammalian cell line. A minimum of 90% confluency within 72 hours is required for lot acceptance.
Quality Management and Control
Falcon IVF products are manufactured in compliance with the current version of the EN ISO 9001 Standard, the EN ISO 13485 Standard, the Medical Device Directive (MDD) 93/42/EEC as amended with 2007/47/EEC, and the FDA CFR 21 Part 820 and current Good Manufacturing Practices (cGMP).
Medical Device Classification
◗ US FDA 510(k) cleared Class II medical device
◗ CE marked in compliance with the European Medical Devices Directive 93/42/EEC as Class IIa medical device
Each lot of Falcon IVF product is tested for embryotoxicity using the one-cell mouse embryo assay. A minimum of 75%, of both test and control embryos, must reach the hatched and/ or expanded blastocyst stage in order for our products to be deemed nonembryotoxic and acceptable for product release.
Additional MEA Testing option available via Embryotech Laboratories - See 353655-MEA
Falcon IVF products are irradiated and dosimetrically released per the requirements of ANSI/ AAMI/ISO 11137 and meet a minimum Sterility Assurance Level (SAL) of 10-6.
Each lot of Falcon IVF product is tested and meets the criteria established in the United States Pharmacopeia (USP) Chapter <85>, “Bacterial Endotoxins Test.” The acceptance level for a product is less than 0.1 EU/mL or 5 EU/device.
Thorough testing is conducted to qualify material resins to USP Class VI. Products are also tested and qualify as noncytotoxic per the requirements of ISO 10993-5, Biological evaluation of medical devices – Tests for in vitro cytotoxicity.
Genotoxicity, Carcinogenicity, and Reproductive Toxicity
Products have been tested and demonstrated to be non-mutagenic and non-genotoxic per the requirements of ISO 10993-3, Biological evaluation of medical devices: Tests for genotoxicity, carcinogenicity, and reproductive toxicity.
Individual certificates, containing actual test results, are available for each lot by contacting your local Corning Life Sciences office after you receive your order.
|| 4 / Pk
|| 100 / Cs
|Mfr. No. 353655
||50mm x 9mm Not TC-Treated In Vitro Fertilization (IVF)/Low Wall Dish, 4Pack, Sterile, 100/Case
Mfr. No 353655-MEA
Additional MEA TESTED - 50mm x 9mm Not TC-Treated In Vitro Fertilization (IVF)/Low Wall Dish, 4Pack, Sterile, 100/Case