| Primary Device ID | 00348783001068 |
| NIH Device Record Key | e146c8c5-c700-4665-9494-bca5ad7298c5 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Hemodent |
| Version Model Number | 9007071 |
| Company DUNS | 014789663 |
| Company Name | PREMIER DENTAL PRODUCTS COMPANY |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| 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 | 00348783001068 [Unit of Use] |
| GS1 | 00348783001075 [Primary] |
| MVL | Cord, Retraction |
| NYF | Gingival Retraction Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-21 |
| Device Publish Date | 2023-06-13 |
| 00348783001105 | Hemodent® liquid 40cc, Pack of 10 |
| 00348783001082 | Hemodent® liquid 20cc, Pack of 10 |
| 00348783001068 | Hemodent® liquid 10cc, Pack of 10 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() HEMODENT 76061177 2495934 Live/Registered |
MEDICAL PRODUCTS LABORATORIES, INC. 2000-06-05 |