Primary Device ID | 00787010222218 |
NIH Device Record Key | 3bff5887-22aa-4b1a-984c-24a54a0fb170 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | The Keeper |
Version Model Number | KA |
Company DUNS | 948902387 |
Company Name | GLADRAGS SUSTAINABLE WOMEN'S HEALTH, LLC |
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 | false |
Device Combination Product | false |
Single Use | false |
Lot Batch | false |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | false |
Donation Id Number | false |
Contains Natural Rubber Latex | true |
Labeled No Natural Rubber Latex | false |
RX Perscription | false |
OTC Over-The-Counter | false |