| Primary Device ID | 00384703560017 |
| NIH Device Record Key | 08043917-a22b-48b7-995d-c0d4fb2b0bea |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Unifine Pentips - 4mm x 33G |
| Version Model Number | AN3560 |
| Catalog Number | AN3560 |
| 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 |
| 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 |
| 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 | 00384703560000 [Unit of Use] |
| GS1 | 00384703560017 [Primary] |
| GS1 | 00384703560024 [Package] Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00384703560031 [Package] Contains: 00384703560024 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 |
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| 00384707312032 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 23G Safety Winged Sets w/ Luer 12" tubing |
| 00384707317037 - Unistik ShieldLock | 2023-10-16 Unistik ShieldLock 23G Safety Winged Set w/ Luer 8" tubing |