| Primary Device ID | 00761059352921 | 
| NIH Device Record Key | c9fa3bdc-d88e-40ad-a5f9-741d92f30021 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Unifine Pentips | 
| Version Model Number | AN 3529AC | 
| 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 | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Needle Gauge | 29 Gauge | 
| Length | 12 Millimeter | 
| Device Issuing Agency | Device ID | 
|---|---|
| GS1 | 00384703529007 [Unit of Use] | 
| GS1 | 00761059352914 [Primary] | 
| GS1 | 00761059352921 [Package] Contains: 00761059352914 Package: Sleeve [10 Units] In Commercial Distribution  | 
| GS1 | 00761059352938 [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 | 2024-01-30 | 
| Device Publish Date | 2024-01-22 | 
| 00761059352921 | Auto Control 1st Tier Unifine Pentips pen needles - 12mm x 29G | 
| 00761059354024 | Auto Control 1st Tier Unifine Pentips pen needles - 4mm x 32G |