AccessGUDID - DEVICE: UNIVERSAL NEURO 3 (07613327412307)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL NEURO 3
Version or Model: 92-34714
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 92-34714
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613327412307
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: SHUNT PLATE, WITH TAB

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
46642	Craniofacial fixation plate, non-bioabsorbable, non-customized	A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
GXR	COVER, BURR HOLE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K112557	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Thickness: 0.4 Millimeter

Device Record Status

Public Device Record Key: 38f8f46c-a0e7-42d4-9062-8779314488a2
Public Version Date: June 09, 2025
Public Version Number: 6
DI Record Publish Date: December 17, 2017