UNIVERSAL NEURO 3 92-34112

GUDID 07613327524147

STRAIGHT PLATE, WITH TAB

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized Craniofacial fixation plate, non-bioabsorbable, non-customized
Primary Device ID07613327524147
NIH Device Record Key0e4c1452-85f9-4b5d-9af6-d0ccef859bd5
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNIVERSAL NEURO 3
Version Model Number92-34112
Catalog Number92-34112
Company DUNS316153956
Company NameStryker Leibinger GmbH & Co. KG
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

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Device Identifiers

Device Issuing AgencyDevice ID
GS107613327524147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GWOPlate, cranioplasty, preformed, alterable

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


[07613327524147]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-22
Device Publish Date2020-10-14

On-Brand Devices [UNIVERSAL NEURO 3]

07613327455786TEMPORAL PLATE, SMALL
07613327420036UN3 BURR HOLE COVER, SEGMENTED
07613327420029UN3 BURR HOLE COVER, SEGMENTED
07613327412307SHUNT PLATE, WITH TAB
07613327314083INSTRUMENT INLAY
07613327314076PLATE INLAY
07613327299182AXS SCREWDRIVER BLADE FOR 1.5MM
07613327292008Gap Plate, small
07613327291995Gap Plate, large
07613327291988Gap Plate, medium
07613327123357UN3 Shunt Plate, with Tab, 20mm
07613327090802AXS SCREWDRIVER BLADE, 1.5MM
07613327090772Screw, AXS, self-tapping
07613327090765Screw, AXS, Emergency
07613327090758Screw, AXS, self-drilling
07613327090741Screw, AXS, self-drilling
07613327090734Screw, AXS, self-drilling
07613327090727Screw, AXS, self-tapping
07613327090710Screw, AXS, self-tapping
07613327090703Screwdisc, Sd, 1.5x5mm AXS, 80Pk
07613327090697Screwdisc, Sd, 1.5x4mm AXS, 80Pk
07613327090680Screwdisc, St, 1.5x5mm AXS, 80Pk
07613327090673Screwdisc, Sd, 1.5x3mm AXS, 80Pk
07613327090604Screwdisc, St, 1.5x4mm AXS, 80Pk
07613252660743Mesh Plate, round, small
07613252660729Mesh Plate, round, large
07613252660712Suboccipital Plate, large
07613252633600SCREW, SELF-DRILLING
07613252633587SCREW, SELF-DRILLING
07613252471547BOX PLATE, SMALL
04546540684851Straight Plate, 12mm Bar
04546540684844Straight Plate
04546540684837X Plate
04546540684820Gap Plate, large
04546540684813Shunt Plate, with Tab, 20mm
04546540684806Shunt Plate, with Tab, 14mm
04546540684790Gap Plate, small
04546540684783Double-Y Plate
04546540684776Burr Hole Cover, with Tab, 24mm
04546540684769Burr Hole Cover, with Tab, 20mm
04546540684752Burr Hole Cover, with Tab, 14mm
04546540684745Burr Hole Cover, with Tab, 10mm
04546540684738Burr Hole Cover, with Tab, 7mm
04546540684721Straight Plate, 6mm Bar
04546540684714Rectangle Plate
04546540684707Box Plate, large
04546540684691Box Plate, large, with Tab
04546540684684Box Plate, small
04546540684677Straight Plate, 16mm Bar
04546540684660Straight Plate, 12mm Bar, with Tab

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