Primary Device ID | 08404535012323 |
NIH Device Record Key | 977a835c-3635-43e0-ba41-a653ff3f02f6 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XP-4D |
Version Model Number | 5031708U0 |
Catalog Number | 5031708U0 |
Company DUNS | 082080136 |
Company Name | Peter Brasseler Holdings, LLC |
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 | 08404535012323 [Primary] |
EKN | Point, Paper, Endodontic |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2025-03-12 |
Device Publish Date | 2025-01-31 |
08404535012354 | XP-4D ABSORBENT PP ASST 100P |
08404535012323 | XP-4D ABSORBENT PP LARGE 100P |
08404535012293 | XP-4D ABSORBENT PP MEDIUM 100P |
08404535012262 | XP-4D ABSORBENT PP STANDARD100P |
08404535012231 | XP-4D ABSORBENT PP STARTER 100P |
08404535012200 | XP-4D BIO GP CONES ASST 60P XP |
08404535012170 | XP-4D BIO GP CONES LARGE 60P X |
08404535012149 | XP-4D BIO GP CONES MEDIUM 60P |
08404535012118 | XP-4D BIO GP CONES STANDARD 60 |
08404535012088 | XP-4D BIO GP CONES STARTER 60P |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() XP-4D 79399927 not registered Live/Pending |
FKG Dentaire SÃ rl 2024-06-20 |