Primary Device ID | D6919053238 |
NIH Device Record Key | 628f2f55-181a-4d55-82c8-126f70266002 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Premier K-FILES |
Version Model Number | 9053238 |
Company DUNS | 014789663 |
Company Name | PREMIER DENTAL PRODUCTS COMPANY |
Device Count | 1 |
DM Exempt | true |
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 |
---|---|
HIBCC | D6919053238 [Primary] |
EKS | File, Pulp Canal, Endodontic |
Steralize Prior To Use | true |
Device Is Sterile | false |
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
[D6919053238]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-10-25 |
Device Publish Date | 2023-10-17 |
D6919053312 | FILES PKG 6 31MM 45-80 |
D6919053311 | FILES PKG 6 31MM 15-40 |
D6919053304 | FILES PKG 6 31MM 80 |
D6919053303 | FILES PKG 6 31MM 70 |
D6919053302 | FILES PKG 6 31MM 60 |
D6919053301 | FILES PKG 6 31MM 55 |
D6919053300 | FILES PKG 6 31MM 50 |
D6919053299 | FILES PKG 6 31MM 45 |
D6919053298 | FILES PKG 6 31MM 40 |
D6919053297 | FILES PKG 6 31MM 35 |
D6919053296 | FILES PKG 6 31MM 30 |
D6919053295 | FILES PKG 6 31MM 25 |
D6919053294 | FILES PKG 6 31MM 20 |
D6919053293 | FILES PKG 6 31MM 15 |
D6919053292 | FILES PKG 6 31MM 10 |
D6919053291 | FILES PKG 6 31MM 08 |
D6919053290 | FILES PKG 6 31MM 06 |
D6919053249 | FILES PKG 6 25MM 45-80 |
D6919053248 | FILES PKG 6 25MM 15-40 |
D6919053244 | FILES PKG 6 25MM 80 |
D6919053243 | FILES PKG 6 25MM 70 |
D6919053242 | FILES PKG 6 25MM 60 |
D6919053241 | FILES PKG 6 25MM 55 |
D6919053240 | FILES PKG 6 25MM 50 |
D6919053239 | FILES PKG 6 25MM 45 |
D6919053238 | FILES PKG 6 25MM 40 |
D6919053237 | FILES PKG 6 25MM 35 |
D6919053236 | FILES PKG 6 25MM 30 |
D6919053235 | FILES PKG 6 25MM 25 |
D6919053234 | FILES PKG 6 25MM 20 |
D6919053233 | FILES PKG 6 25MM 15 |
D6919053232 | FILES PKG 6 25MM 10 |
D6919053231 | FILES PKG 6 25MM 08 |
D6919053230 | FILES PKG 6 25MM 06 |
D6919053219 | FILES PKG 6 21MM 45-80 |
D6919053218 | FILES PKG 6 21MM 15-40 |
D6919053212 | FILES PKG 6 21MM 60 |
D6919053211 | FILES PKG 6 21MM 55 |
D6919053210 | FILES PKG 6 21MM 50 |
D6919053209 | FILES PKG 6 21MM 45 |
D6919053208 | FILES PKG 6 21MM 40 |
D6919053207 | FILES PKG 6 21MM 35 |
D6919053206 | FILES PKG 6 21MM 30 |
D6919053205 | FILES PKG 6 21MM 25 |
D6919053204 | FILES PKG 6 21MM 20 |
D6919053203 | FILES PKG 6 21MM 15 |
D6919053202 | FILES PKG 6 21MM 10 |
D6919053201 | FILES PKG 6 21MM 08 |
D6919053200 | FILES PKG 6 21MM 06 |