Primary Device ID | D8451031105 |
NIH Device Record Key | 53d3d987-c0bd-458c-89e4-deb24bf9183a |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMPACT-20 |
Version Model Number | 1031105 |
Catalog Number | 1031105 |
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 | D8451031105 [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 |
D8451031317 | IMPACT-20, VIR, 11.3 kg |
D8451031316 | IMPACT-20, ORI, 11.3 kg |
D8451031309 | IMPACT-20, CUSTOM, 11.3 kg |
D8451031307 | IMPACT-20, MDP, 11.3 kg |
D8451031305 | IMPACT-20, LPI, 11.3 kg |
D8451031304 | IMPACT-20, SPI, 11.3 kg |
D8451031303 | IMPACT-20, RPI, 11.3 kg |
D8451031302 | IMPACT-20, LPL, 11.3 kg |
D8451031301 | IMPACT-20, SPL, 11.3 kg |
D8451031217 | IMPACT-20, VIR, 2.3 kg |
D8451031216 | IMPACT-20, ORI, 2.3 kg |
D8451031207 | IMPACT-20, MDP, 2.3 kg |
D8451031205 | IMPACT-20, LPI, 2.3 kg |
D8451031204 | IMPACT-20, SPI, 2.3 kg |
D8451031203 | IMPACT-20. RPI, 2.3 kg |
D8451031202 | IMPACT-20, LPL, 2.3 kg |
D8451031201 | IMPACT-20, SPL, 2.3 kg |
D8451031117 | IMPACT-20, VIR, 454 g |
D8451031116 | IMPACT-20, ORI, 454 g |
D8451031107 | IMPACT-20, MDP, 454 g |
D8451031105 | IMPACT-20, LPI, 454 g |
D8451031104 | IMPACT-20, SPI, 454 g |
D8451031103 | IMPACT-20, RPI, 454 g |
D8451031102 | IMPACT-20, LPL, 454 g |
D84510311010 | Impact-20, 1 lbs, SPL |
D8451031101 | IMPACT-20, SPL, 454 g |