Primary Device ID | 60888937021815 |
NIH Device Record Key | 827f2cac-3721-493c-8fdf-c14020dfcdbb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Embryo Biopsy Kit |
Version Model Number | 096.101016.V1 |
Company DUNS | 801895244 |
Company Name | Coopersurgical, Inc. |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | true |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | true |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | true |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 60888937021815 [Primary] |
NNK | Container, Specimen Mailer And Storage, Non-Sterile |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2020-02-24 |
Device Publish Date | 2020-02-14 |
60888937027176 - ERPeak | 2024-04-18 IVD Sample kit |
60888937027183 - ERPeak | 2024-04-18 IVD Sample kit |
60888937027190 - ERPeak | 2024-04-18 IVD Sample kit |
60888937027206 - ERPeak | 2024-04-18 IVD Sample kit |
00888937026870 - Mara Console | 2024-03-21 Mara Console- Endometrial Ablation |
00888937023817 - K-Systems | 2024-02-27 L126 IVF, Standard Heat Right |
00888937023824 - K-Systems | 2024-02-27 L126 IVF, Standard Heat Right |
00888937023831 - K-Systems | 2024-02-27 L126 IVF, RI Witness Right |