| Primary Device ID | 00810235030884 |
| NIH Device Record Key | e516b4eb-92bf-427f-8dfc-39942216f753 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | US Rigid Injection Needle with Huber Point |
| Version Model Number | 9001M0 |
| Company DUNS | 028147846 |
| Company Name | MERZ NORTH AMERICA, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00810235030884 [Primary] |
| GAA | Needle, Aspiration And Injection, Disposable |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-13 |
| Device Publish Date | 2026-03-05 |
| 00810235030860 - US Accessory Kit | 2026-03-13 One Needle, One female to female luer lock connector, and one, 3mL Syringe |
| 00810235030877 - US Rigid Needle with Support Cannula- Double Bevel | 2026-03-13 US Rigid Needle with Support Cannula- Double Bevel |
| 00810235030884 - US Rigid Injection Needle with Huber Point | 2026-03-13US Rigid Injection Needle with Huber Point |
| 00810235030884 - US Rigid Injection Needle with Huber Point | 2026-03-13 US Rigid Injection Needle with Huber Point |
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| 08714729804796 - Coaptite | 2022-01-19 The Coaptite Injectable Implant is a permanently implanted device used to treat women who have severe stress urinary incontinenc |
| 00186295000342 - DeScribe Transparent PFD Patch | 2018-03-29 Individually packaged DeScribe PFD Patch (each) Contains 5 DeScribe PFD Patches. |