| Primary Device ID | 00761059861843 |
| NIH Device Record Key | 93187eea-9a86-4236-b749-40df06927c06 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Diabetic Outlet 1st Tier - Unifine Pentips Plus 4mm x 33G |
| Version Model Number | AN 3860DO |
| 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 | true |
| RX Perscription | true |
| OTC Over-The-Counter | true |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Length | 4 Millimeter |
| Needle Gauge | 33 Gauge |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384703860001 [Unit of Use] |
| GS1 | 00761059860846 [Primary] |
| GS1 | 00761059861843 [Package] Contains: 00761059860846 Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00761059862840 [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 | 2021-06-04 |
| Device Publish Date | 2021-05-27 |
| 00384703160019 - Empelvic | 2025-09-08 Pelvic Floor Trainer - Femail |
| 00384703150010 - Empelvic | 2025-09-01 Pelvic Floor Trainer - Femail |
| 00384703155015 - Empelvic | 2025-09-01 Pelvic Floor Trainer - Male |
| 00761059640028 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needle 4mm x 32G 100 ct |
| 00761059641032 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needles 4mm x 32G 50 ct |
| 00761059650027 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needle, 5mm x 31G, 100 ct |
| 00761059651031 - Unifine OTC | 2025-02-24 Unifine OTC Pen Needle, 5mm x 31G, 50 ct |
| 00761059354024 - Unifine Pentips | 2024-02-13 Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G |