| Primary Device ID | 20370797011010 |
| NIH Device Record Key | f8cbef21-5785-48f5-bab8-8e35ab8622f8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dr. Talbot's |
| Version Model Number | 1101 |
| Company DUNS | 078855555 |
| Company Name | TALBOT'S PHARMACEUTICALS FAMILY PRODUCTS, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | false |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00370797011016 [Primary] |
| GS1 | 20370797011010 [Package] Contains: 00370797011016 Package: [6 Units] In Commercial Distribution |
| GS1 | 30370797011017 [Package] Package: [4 Units] In Commercial Distribution |
| CEP | Radioimmunoassay, Luteinizing Hormone |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-11-02 |
| Device Publish Date | 2020-10-23 |