| Primary Device ID | D9281051992HD0 |
| NIH Device Record Key | 3043ec44-5a01-4773-a692-6a12c6d4b056 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SINUS INSTRUMENT #2 HD D/E |
| Version Model Number | 10-5199-2HD |
| Company DUNS | 183854322 |
| Company Name | W.H. Holden, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D9281051992HD0 [Primary] |
| GFI | Osteotome, Manual |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
[D9281051992HD0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-04-02 |
| Device Publish Date | 2025-03-25 |