Primary Device ID | 00815967020462 |
NIH Device Record Key | e4c5ae3c-d555-4cb6-9f14-6de849935d1d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Pac-Dent |
Version Model Number | CS250 |
Company DUNS | 959077454 |
Company Name | PAC-DENT INTERNATIONAL INC |
Device Count | 20 |
DM Exempt | false |
Pre-market Exempt | false |
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 | false |
OTC Over-The-Counter | false |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00815967020455 [Unit of Use] |
GS1 | 00815967020462 [Primary] |
PEM | Dental Barriers And Sleeves |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2018-03-29 |
Device Publish Date | 2016-08-29 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() PAC-DENT 88938193 not registered Live/Pending |
Pac-Dent, Inc. 2020-05-28 |