QUIKFLAP, UNIVERSAL NEURO 2 13-05514

GUDID 04546540491138

LOW PROFILE BURR HOLE COVER, W/TAB, 14mm

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable
Primary Device ID04546540491138
NIH Device Record Keyf09d6ac7-ff3c-434d-96f4-8952d57cf301
Commercial Distribution StatusIn Commercial Distribution
Brand NameQUIKFLAP, UNIVERSAL NEURO 2
Version Model Number13-05514
Catalog Number13-05514
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS104546540491138 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JEYPLATE, BONE

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-09-24

On-Brand Devices [QUIKFLAP, UNIVERSAL NEURO 2]

076131546198492 HOLE PLATES(3) SELF DRILLING SCREW(6)
04546540491145LOW PROFILE BURR HOLE COVER, W/TAB,20mm
04546540491138LOW PROFILE BURR HOLE COVER, W/TAB, 14mm
04546540491121LOW PROFILE BURR HOLE COVER, W/TAB, 10mm
04546540491114LOW PROFILE BURR HOLE COVER, W/TAB, 7mm

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