| Primary Device ID | D928106052B2B0 |
| NIH Device Record Key | 59381df4-6b96-40be-88b9-f09bad999250 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MOUTH PROP ADULT BITE BLOCK WITHOUT ATTACHMENT BEAUDRY STYLE |
| Version Model Number | 10-6052B-2B |
| 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 | D928106052B2B0 [Primary] |
| KBN | Gag, Mouth |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
[D928106052B2B0]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-26 |
| Device Publish Date | 2024-12-18 |
| D928106054B2B0 | 10-6054B-2B |
| D928106052B2B0 | 10-6052B-2B |