Primary Device ID | D6919007559 |
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 |
---|---|
HIBCC | D6919007559 [Primary] |
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 | 2022-07-07 |
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 |