FDA-Device2016-09-28Class III
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
CooperSurgical, Inc.
Hazard
Products contain international package insert and not the correct USA package insert
Sold states
Nationwide Distribution to CA, GA, and NY
Affected count
4 units
Manufactured in
95 Corporate Dr, Trumbull, CT, United States
Products
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2851-2016Don't want to check this manually?
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