| Primary Device ID | 00384703595033 |
| NIH Device Record Key | 29d87184-341b-4ebf-8031-aff5473c6aa7 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unifine Pentips - 6mm x 32G |
| Version Model Number | AN3595 |
| Catalog Number | AN3595 |
| 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 | 6 Millimeter |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 32 Gauge |
| Length | 6 Millimeter |
| 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 | 00384703595002 [Unit of Use] |
| GS1 | 00384703595019 [Primary] |
| GS1 | 00384703595026 [Package] Contains: 00384703595019 Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00384703595033 [Package] Contains: 00384703595026 Package: Case [50 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 | 2018-11-05 |
| Device Publish Date | 2018-10-03 |
| 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 |