| Primary Device ID | D928105382020 |
| NIH Device Record Key | 46d4756e-8316-43bf-a1fc-66cc9837b1fc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BONE CHISEL 4MM, 6" S/E |
| Version Model Number | 10-5382-02 |
| 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 | D928105382020 [Primary] |
| EMM | Chisel, Osteotome, Surgical |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
[D928105382020]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-03-27 |
| Device Publish Date | 2025-03-19 |