| Primary Device ID | 00761059430025 |
| NIH Device Record Key | fdb54f49-7c08-433b-bedd-5699332504cf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Pentips 1st Tier |
| Version Model Number | AN 3430FT |
| 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 | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 8 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384703430006 [Unit of Use] |
| GS1 | 00761059430018 [Primary] |
| GS1 | 00761059430025 [Package] Contains: 00761059430018 Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00761059430032 [Package] Package: Case [5 Units] In Commercial Distribution |
| FMI | Needle, Hypodermic, Single Lumen |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-03 |
| Device Publish Date | 2023-06-23 |
| 00761059490029 | Pentips 1st Tier pen needles, 6mm x 31G |
| 00761059450023 | Pentips 1st Tier pen needles Mini, 5mm x 31G |
| 00761059440024 | Pentips 1st tier pen needles, 4mm x 32G |
| 00761059430025 | Pentips 1st Tier pen needles Short, 8mm x 31G |
| 00761059429029 | Pentips 1st Tier pen needles Original, 12mm x 29G |