| Primary Device ID | 00761059257004 |
| NIH Device Record Key | 6c4ecebd-ca09-4893-8440-30e02f24f22e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | 1st Tier Unilet Comfortouch |
| Version Model Number | AT 0925FT |
| Company DUNS | 803401454 |
| Company Name | OWEN MUMFORD USA INCORPORATED |
| Device Count | 100 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| 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 | true |
| OTC Over-The-Counter | true |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Needle Gauge | 28 Gauge |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00761059257004 [Unit of Use] |
| GS1 | 00761059257363 [Primary] |
| QRK | Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-04-07 |
| Device Publish Date | 2023-03-30 |
| 00761059657002 | 1st Tier Unilet Comfortouch 30G |
| 00761059257004 | 1st Tier Unilet Comfortouch Lancets 28G |