IMPACT-PLUS 1011101

GUDID D8451011101

IMPACT-PLUS, SLP, 454 g

Denplus Inc

Dental appliance fabrication material, cured
Primary Device IDD8451011101
NIH Device Record Key6752db13-2219-4a0a-bcdd-6fc26492be62
Commercial Distribution StatusIn Commercial Distribution
Brand NameIMPACT-PLUS
Version Model Number1011101
Catalog Number1011101
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
HIBCCD8451011101 [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 Date2018-04-30

On-Brand Devices [IMPACT-PLUS]

D8451011317IMPACT-PLUS, VIR, 11.3 kg
D8451011316IMPACT-PLUS, ORI, 11.3 kg
D8451011309IMPACT-PLUS, CUSTOM, 11.3 kg
D8451011307IMPACT-PLUS, MDP, 11.3 kg
D8451011305IMPACT-PLUS, LPI, 11.3 kg
D8451011304IMPACT-PLUS, SPI, 11.3 kg
D8451011303IMPACT-PLUS, RPI, 11.3 kg
D8451011302IMPACT-PLUS,LPL, 11.3 kg
D8451011301IMPACT-PLUS, SPL, 11.3 kg
D8451011217IMPACT-PLUS, VIR, 2.3 kg
D8451011216IMPACT-PLUD, ORI, 2.3kg
D8451011207IMPACT-PLUS, MDP, 2.3 kg
D8451011205IMPACT-PLUS, LPI, 2.3 kg
D8451011204iMPACT-PLUS, SPI.
D8451011203IMPACT-PLUS, RPI, 2.3 kg
D8451011202IMPACT-PLUS, LPL, 2.3 kg
D8451011201IMPACT-PLUS, SLP, 2.3 kg
D8451011117IMPACT-PLUS, VIR, 454 g
D8451011116IMMPACT-PLUS, ORI, 454 g
D8451011107IMPACT-PLUS, MDP,454 g
D8451011105IMPACT-PLUS, LPI, 454 g
D8451011104IMPACT-PLUS, SPI, 454 g
D8451011103IMPACT-PLUS, RPI, 454 g
D8451011102IMPACT-PLUS, LPL, 454 g
D8451011101IMPACT-PLUS, SLP, 454 g

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