Primary Device ID | D8451141309 |
NIH Device Record Key | 64b3887e-383d-4f04-8c56-aad33614a1ac |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | HIGH-WAVE |
Version Model Number | 1141309 |
Catalog Number | 1141309 |
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 | D8451141309 [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 | 2018-05-02 |
D8451142200 | HIGH-WAVE LIQUID, 1 L |
D8451142100 | HIGH-WAVE LIQUID, 250 ml |
D8451141317 | HIGH-WAVE, VIR, 11.3 kg |
D8451141316 | HIGH-WAVE, ORI, 11.3 kg |
D8451141309 | HIGH-WAVE, CUSTOM, 11.3 kg |
D8451141307 | HIGH-WAVE, MDP, 11.3 kg |
D8451141302 | HIGH-WAVE, LPL, 11.3 kg |
D8451141217 | HIGH-WAVE, VIR, 2.3 kg |
D8451141216 | HIGH-WAVE, ORI, 2.3 kg |
D8451141207 | HIGH-WAVE, MDP, 2.3 kg |
D8451141202 | HIGH-WAVE, LPL, 2.3 kg |
D8451141117 | HIGH-WAVE, VIR, 454 g |
D8451141116 | HIGH-WAVE, ORI, 454 g |
D8451141107 | HIGH-WAVE, MDP, 454 g |
D8451141102 | HIGH-WAVE, LPL, 454 g |