| Primary Device ID | 00761059551850 |
| NIH Device Record Key | e2e47858-0ec8-4497-ab27-4a91a7df5460 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | South Pointe Wholesale - Unifine Pentips |
| Version Model Number | AN 3550SPW |
| 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 |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com | |
| Phone | 770-977-2226 |
| USCustomerService@owenmumford.com |
| 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 |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Handling Environment Temperature | Between 5 Degrees Celsius and 40 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00384703530003 [Unit of Use] |
| GS1 | 00761059550853 [Primary] |
| GS1 | 00761059551850 [Package] Contains: 00761059550853 Package: Sleeve [10 Units] In Commercial Distribution |
| GS1 | 00761059552857 [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 | 2021-11-15 |
| Device Publish Date | 2021-11-05 |
| 00761059591856 | 1st Tier 6mm x 31G pen needles |
| 00761059551850 | 1st Tier 5mm x 31g pen needles |
| 00761059541851 | 1st Tier 4mm x 32G pen needles |
| 00761059531852 | 1st Tier 8mm x 31G pen needles |