DESCRIPTION
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DESCRIPTION
Innovative features for quality and ease-of-use
- Intended use is in vitro fertilization
- CE marked according to Medical Devices Directive 93/42/EEC
- Produced and marketed in compliance with the FDA demands for IVF products
- Full batch control of all components in the final product for full traceability
- Certificates of conformity available for every lot
- CE-marked, FDA cleared and MEA tested
- Produced under ISO 13485 with full lot traceability
- Sterile (SAL 10-6)
- Non-pyrogenic (LAL test)
- USP Class VI test
- Release test results (MEA)
| Mfr No. 150270 | Dish 60 X 15mm, IVF, Non-Treated, Sterile, 510K Cleared. (Case of 400) |
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