Karl Schumacher SHIELD Plus

GUDID 00842517100190

Regenerative Collagen Dental Membrane

KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

Collagen dental regeneration membrane
Primary Device ID00842517100190
NIH Device Record Key9900b6cb-2e3b-4888-a14f-a44d17e8d705
Commercial Distribution StatusIn Commercial Distribution
Brand NameKarl Schumacher SHIELD Plus
Version Model NumberRCMS1520
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
GS100842517100190 [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 Date2017-10-10

Devices Manufactured by KARL SCHUMACHER DENTAL INSTRUMENT CO., INC.

00842517102545 - Karl Schumacher2023-11-22 Sm Str Proximator, 2.5mm Wide Tip, Green
00842517102552 - Karl Schumacher2023-11-22 Lg Str Proximator, 4.5mm Wide Tip, Green
00842517102569 - Karl Schumacher2023-11-22 Sm Cvd Proximator, 2.5mm Wide Tip, Blue
00842517102576 - Karl Schumacher2023-11-22 Lg Cvd Proximator, 4.5mm Wide Tip, Blue
00842517102583 - Karl Schumacher2023-11-22 Spade Proximator, Yellow
00842517102590 - Karl Schumacher2023-11-22 Aetranox Spade Proximator, Yellow
00842517102613 - Karl Schumacher2023-11-22 Sm Distal Ang Proximator, 2.5mm, Purple
00842517102620 - Karl Schumacher2023-11-22 Sm Mesial Ang Proximator, 2.5mm, Purple

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