Primary Device ID | D8451151302 |
NIH Device Record Key | a04a0578-0a11-4b89-846f-c7cdc67cb7ff |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | POUR-PLUS |
Version Model Number | 1151302 |
Catalog Number | 1151302 |
Company DUNS | 202016064 |
Company Name | Denplus Inc |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | MR Safe |
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 | true |
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 | D8451151302 [Primary] |
EBI | Resin, Denture, Relining, Repairing, Rebasing |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 3 |
Public Version Date | 2018-07-06 |
Device Publish Date | 2018-04-30 |
D8451152200 | POUR-PLUS LIQUID, 500 ml |
D8451152100 | POUR-PLUS LIQUID, 250 ml |
D8451151316 | POUR-PLUS, ORI, 11.3 kg |
D8451151307 | POUR-PLUS, MDP, 11.3 kg |
D8451151305SF0 | POUR-PLUS, LPI, WITHOUT FIBERS, 11.3 kg |
D8451151305 | POUR-PLUS, LPI, 11.3 kg |
D8451151302 | POUR-PLUS, LPL, 11.3 kg |
D8451151300 | POUR-PLUS, CLR, 11.3 kg |
D8451151216 | POUR-PLUS, ORI, 2.3 kg |
D8451151207 | POUR-PLUS, MDP, 2.3 kg |
D8451151205 | POUR-PLUS, LPI, 2.3 kg |
D8451151202 | POUR-PLUS, LPL, 2.3 kg |
D8451151200 | POUR-PLUS, CLR, 2.3 kg |
D8451151116 | POUR-PLUS, ORI, 454 g |
D8451151107 | POUR-PLUS, MDP, 454 g |
D8451151105 | POUR-PLUS, LPI, 454 g |
D8451151102 | POUR-PLUS, LPL, 454 g |
D8451151100 | POUR-PLUS, CLR, 454 g |