| Primary Device ID | 00348783004717 |
| NIH Device Record Key | 42d2d832-6565-4b77-b5ac-f7f7e0f88522 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Coated Graves Specula |
| Version Model Number | 9086165 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00348783004717 [Primary] |
| HDF | Speculum, Vaginal, Metal |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
[00348783004717]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-08-14 |
| Device Publish Date | 2024-08-06 |
| 00348783004755 | Coated Graves Specula Large |
| 00348783004748 | Coated Graves Specula Medium |
| 00348783004731 | Coated Graves Specula Small |
| 00348783004724 | Coated Graves Specula Wide Large |
| 00348783004717 | Coated Graves Specula Wide Medium |