PMMA Disc / W-98-14-PD-A300-MT

GUDID 00842271162649

SAGEMAX BIOCERAMICS, INC

Dental crown/bridge resin, temporary
Primary Device ID00842271162649
NIH Device Record Key5e609fec-02d0-49a3-90d2-6f4487193f18
Commercial Distribution StatusIn Commercial Distribution
Brand NamePMMA Disc / W-98-14-PD-A300-MT
Version Model NumberW-73010
Company DUNS002265727
Company NameSAGEMAX BIOCERAMICS, INC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
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
GS100842271162649 [Primary]

FDA Product Code

EBGCrown And Bridge, Temporary, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-03-25
Device Publish Date2020-03-17

Devices Manufactured by SAGEMAX BIOCERAMICS, INC

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00842271162373 - PMMA Disc / A-71-13-PD-A350-MT2020-03-26
00842271162366 - PMMA Disc / A-71-20-PD-A300-MT2020-03-26
00842271162359 - PMMA Disc / A-71-13-PD-A300-MT2020-03-26
00842271162342 - PMMA Disc / A-71-20-PD-A200-MT2020-03-26

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