| Primary Device ID | 00384700190224 |
| NIH Device Record Key | ebf17183-eec4-4b96-8e59-2a7e391530e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unifine Ultra |
| Version Model Number | AN 0190SB2 |
| Company DUNS | 803401454 |
| Company Name | OWEN MUMFORD USA INCORPORATED |
| Device Count | 2 |
| 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 |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 Gauge |
| Length | 6 Millimeter |
| Needle Gauge | 31 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384700190217 [Primary] |
| GS1 | 00384700190224 [Package] Contains: 00384700190217 Package: Case [500 Units] In Commercial Distribution |
| GS1 | 00384704190008 [Unit of Use] |
| 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 | 2022-03-28 |
| Device Publish Date | 2022-03-18 |
| 00384704190039 | Unifine Ultra Pen Needles - 6mm x 31G |
| 00384704150033 | Unifine Ultra Pen Needle - 5mm x 31G |
| 00384704140034 | Unifine Ultra Pen Needles - 4mm x 32G |
| 00384704130035 | Unifine Ultra Pen Needles - 8mm x 31G |
| 00384700140229 | Unifine Ultra Pen Needles sample bag - 4mm x 32G |
| 00384700190224 | Unifine Ultra Pen Needle sample bag - 6mm x 31G |
| 00384700150228 | Unifine Ultra Pen Needle sample bag - 5mm x 31G |
| 00384700130220 | Unifine Ultra Pen Needle sample bag - 8mm x 31G |