Embryo Biopsy Kit

GUDID 60888937021815

Embryo Biopsy Kit

Coopersurgical, Inc.

General specimen container IVD, preservation solution, non-sterile
Primary Device ID60888937021815
NIH Device Record Key827f2cac-3721-493c-8fdf-c14020dfcdbb
Commercial Distribution StatusIn Commercial Distribution
Brand NameEmbryo Biopsy Kit
Version Model Number096.101016.V1
Company DUNS801895244
Company NameCoopersurgical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS160888937021815 [Primary]

FDA Product Code

NNKContainer, Specimen Mailer And Storage, Non-Sterile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-02-24
Device Publish Date2020-02-14

Devices Manufactured by Coopersurgical, Inc.

00888937028126 - Biopsy Medium2026-02-12 Biopsy Medium. 10 ml
00888937028157 - Sperm Freezing Medium2026-02-12 Sperm Freezing Medium. 10ml
00888937028218 - PVP Medium2026-02-12 PVP Medium with phenol red. 1 ml
60888937028272 - Universal IVF Medium2026-02-12 Universal IVF Medium. 60 ml
00888937028287 - Universal IVF Medium2026-02-12 Universal IVF Medium with phenol red. 60 ml
00888937028317 - UTM2026-02-12 UTM Transfer Medium with phenol red. 10 ml
00888937028324 - UTM2026-02-12 UTM Transfer Medium
00888937028577 - Flushing Medium2026-02-12 Flushing Medium without Heparin. 125 ml

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