| Primary Device ID | D9284005451HF0 |
| NIH Device Record Key | f5f2de13-a082-4702-b797-e7f710bf4098 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | VESTIBULAR TUNNELING ELEVATOR #1 D/E HF HANDLE |
| Version Model Number | 40-0545-1HF |
| 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 | D9284005451HF0 [Primary] |
| EMO | Knife, Periodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
Moist Heat or Steam Sterilization
[D9284005451HF0]
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 |