IMPACT-20 1031101

GUDID D8451031101

IMPACT-20, SPL, 454 g

Denplus Inc

Dental appliance fabrication material, cured
Primary Device IDD8451031101
NIH Device Record Key7982d5a2-8431-4c07-831a-a801fac241c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPACT-20
Version Model Number1031101
Catalog Number1031101
Company DUNS202016064
Company NameDenplus Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD8451031101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBIResin, Denture, Relining, Repairing, Rebasing

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2018-05-02

On-Brand Devices [IMPACT-20]

D8451031317IMPACT-20, VIR, 11.3 kg
D8451031316IMPACT-20, ORI, 11.3 kg
D8451031309IMPACT-20, CUSTOM, 11.3 kg
D8451031307IMPACT-20, MDP, 11.3 kg
D8451031305IMPACT-20, LPI, 11.3 kg
D8451031304IMPACT-20, SPI, 11.3 kg
D8451031303IMPACT-20, RPI, 11.3 kg
D8451031302IMPACT-20, LPL, 11.3 kg
D8451031301IMPACT-20, SPL, 11.3 kg
D8451031217IMPACT-20, VIR, 2.3 kg
D8451031216IMPACT-20, ORI, 2.3 kg
D8451031207IMPACT-20, MDP, 2.3 kg
D8451031205IMPACT-20, LPI, 2.3 kg
D8451031204IMPACT-20, SPI, 2.3 kg
D8451031203IMPACT-20. RPI, 2.3 kg
D8451031202IMPACT-20, LPL, 2.3 kg
D8451031201IMPACT-20, SPL, 2.3 kg
D8451031117IMPACT-20, VIR, 454 g
D8451031116IMPACT-20, ORI, 454 g
D8451031107IMPACT-20, MDP, 454 g
D8451031105IMPACT-20, LPI, 454 g
D8451031104IMPACT-20, SPI, 454 g
D8451031103IMPACT-20, RPI, 454 g
D8451031102IMPACT-20, LPL, 454 g
D84510311010Impact-20, 1 lbs, SPL
D8451031101IMPACT-20, SPL, 454 g

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