| Primary Device ID | D9282001491H0 |
| NIH Device Record Key | e84f3bc4-cddd-4b33-b78b-ab38dc18fe81 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OSTEOTOME, 7", 4mm SLIGHT CURVE MARKINGS 12-9-6-3mm, HEXED HANDLE |
| Version Model Number | 20-0149-1H |
| 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 | D9282001491H0 [Primary] |
| EMM | Chisel, Osteotome, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
[D9282001491H0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-14 |
| Device Publish Date | 2026-01-06 |