| Primary Device ID | 00348783001921 |
| NIH Device Record Key | 4ea02c00-32d2-4bfa-862d-fa4d8c0cd7e6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Knit-Pak |
| Version Model Number | 9007559 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| 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 | 00348783001921 [Primary] |
| NYF | Gingival Retraction Kit |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2024-01-10 |
| Device Publish Date | 2022-06-29 |
| D6919007559 | SAMPLE – Knit-Pak™ Knitted Retraction Size 00 (19.7”) |
| D6919007556 | Knit-Pak™ Knitted Retraction Size 3 |
| D6919007555 | Knit-Pak™ Knitted Retraction Size 2 |
| D6919007554 | Knit-Pak™ Knitted Retraction Size 1 |
| D6919007553 | Knit-Pak™ Knitted Retraction Size 0 |
| D6919007552 | Knit-Pak™ Knitted Retraction Size 00 |
| D6919007551 | Knit-Pak™ Knitted Retraction Size 000 |
| 00348783001921 | SAMPLE – Knit-Pak™ Knitted Retraction Size 00 (19.7”) |
| 00348783001914 | Knit-Pak™ Knitted Retraction Size 3 |
| 00348783001907 | Knit-Pak™ Knitted Retraction Size 2 |
| 00348783001891 | Knit-Pak™ Knitted Retraction Size 1 |
| 00348783001884 | Knit-Pak™ Knitted Retraction Size 0 |
| 00348783001877 | Knit-Pak™ Knitted Retraction Size 00 |
| 00348783001860 | Knit-Pak™ Knitted Retraction Size 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() KNIT-PAK 72250044 0839196 Dead/Expired |
SOUTHERN MILLS, INC. 1966-07-11 |