| Primary Device ID | 00761059429029 | 
| NIH Device Record Key | ee143a78-2ff1-48dc-9c58-aba0ce3400b4 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | Pentips 1st Tier | 
| Version Model Number | AN 3429FT | 
| 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 | 
| 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 | 00384703429000 [Unit of Use] | 
| GS1 | 00761059429012 [Primary] | 
| GS1 | 00761059429029 [Package] Contains: 00761059429012 Package: Sleeve [10 Units] In Commercial Distribution  | 
| GS1 | 00761059429036 [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 | 2023-07-03 | 
| Device Publish Date | 2023-06-23 | 
| 00761059490029 | Pentips 1st Tier pen needles, 6mm x 31G | 
| 00761059450023 | Pentips 1st Tier pen needles Mini, 5mm x 31G | 
| 00761059440024 | Pentips 1st tier pen needles, 4mm x 32G | 
| 00761059430025 | Pentips 1st Tier pen needles Short, 8mm x 31G | 
| 00761059429029 | Pentips 1st Tier pen needles Original, 12mm x 29G |