UNIVERSAL NEURO 2, UNIVERSAL NEURO III 54-00645

GUDID 04546540684875

DYNAMIC MESH STD F. 1.5/1.7MM SCREWS

Stryker Leibinger GmbH & Co. KG

Craniofacial fixation plate, non-bioabsorbable

Primary Device ID	04546540684875
NIH Device Record Key	ef45790c-3cbe-4e70-8f84-b37edd5b4b67
Commercial Distribution Status	In Commercial Distribution
Brand Name	UNIVERSAL NEURO 2, UNIVERSAL NEURO III
Version Model Number	54-00645
Catalog Number	54-00645
Company DUNS	316153956
Company Name	Stryker Leibinger GmbH & Co. KG
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Dimensions

Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter
Device Size Text, specify	0
Length	120 Millimeter
Width	120 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	04546540684875 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K983528

FDA Product Code

JEY	PLATE, BONE

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

[04546540684875]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	3
Public Version Date	2018-07-06
Device Publish Date	2015-09-24

On-Brand Devices [UNIVERSAL NEURO 2, UNIVERSAL NEURO III]

04546540684875	DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
04546540684868	DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS
04546540684431	LID UNIV.NEURO CONTAINER,QUARTER-SIZE
04546540684424	UNIVERSAL CONTAINER, QUARTER-SIZE
04546540684417	LIFT OUT INLAY COMBINED TRAY
04546540684400	SILICONE MAT COMBINED TRAY
04546540684394	COMBINED TRAY, UNIVERSAL NEURO
04546540684387	LID, COMBINED TRAY
04546540543028	DRILL, WL 6MM, STRYKER SHAFT
04546540394170	SCREWDRIVER HANDLE, TEAL
04546540237668	DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
04546540237651	DYNAMIC MESH STD F. 1.5/1.7MM SCREWS
04546540237606	DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS
04546540237590	DYNAMIC MESH MALL. F. 1.5/1.7MM SCREWS
04546540237569	Micro Mesh
04546540237538	Micro Mesh

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