Primary Device ID | D8451011302 |
NIH Device Record Key | 88021b2e-0ef3-48ad-a93f-1c356d29b4c2 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | IMPACT-PLUS |
Version Model Number | 1011302 |
Catalog Number | 1011302 |
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 | D8451011302 [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 |
D8451011317 | IMPACT-PLUS, VIR, 11.3 kg |
D8451011316 | IMPACT-PLUS, ORI, 11.3 kg |
D8451011309 | IMPACT-PLUS, CUSTOM, 11.3 kg |
D8451011307 | IMPACT-PLUS, MDP, 11.3 kg |
D8451011305 | IMPACT-PLUS, LPI, 11.3 kg |
D8451011304 | IMPACT-PLUS, SPI, 11.3 kg |
D8451011303 | IMPACT-PLUS, RPI, 11.3 kg |
D8451011302 | IMPACT-PLUS,LPL, 11.3 kg |
D8451011301 | IMPACT-PLUS, SPL, 11.3 kg |
D8451011217 | IMPACT-PLUS, VIR, 2.3 kg |
D8451011216 | IMPACT-PLUD, ORI, 2.3kg |
D8451011207 | IMPACT-PLUS, MDP, 2.3 kg |
D8451011205 | IMPACT-PLUS, LPI, 2.3 kg |
D8451011204 | iMPACT-PLUS, SPI. |
D8451011203 | IMPACT-PLUS, RPI, 2.3 kg |
D8451011202 | IMPACT-PLUS, LPL, 2.3 kg |
D8451011201 | IMPACT-PLUS, SLP, 2.3 kg |
D8451011117 | IMPACT-PLUS, VIR, 454 g |
D8451011116 | IMMPACT-PLUS, ORI, 454 g |
D8451011107 | IMPACT-PLUS, MDP,454 g |
D8451011105 | IMPACT-PLUS, LPI, 454 g |
D8451011104 | IMPACT-PLUS, SPI, 454 g |
D8451011103 | IMPACT-PLUS, RPI, 454 g |
D8451011102 | IMPACT-PLUS, LPL, 454 g |
D8451011101 | IMPACT-PLUS, SLP, 454 g |