Karl Schumacher FLEX

GUDID 00842517102255

Regenerative Collagen Dental Membrane

KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

Collagen dental regeneration membrane
Primary Device ID00842517102255
NIH Device Record Keyba49308f-cf98-4eb0-8a75-d2274e62d360
Commercial Distribution StatusIn Commercial Distribution
Brand NameKarl Schumacher FLEX
Version Model NumberRCMF3040
Company DUNS043957315
Company NameKARL SCHUMACHER DENTAL INSTRUMENT CO., 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 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 Dimensions

Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
GS100842517102255 [Primary]

FDA Product Code

NPLBarrier, Animal Source, Intraoral

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2017-09-26

On-Brand Devices [Karl Schumacher FLEX]

00842517102255Regenerative Collagen Dental Membrane
00842517102248Regenerative Collagen Dental Membrane
00842517102231Regenerative Collagen Dental Membrane

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