AccessGUDID - DEVICE: UNIVERSAL NEURO 3 (04546540684639)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL NEURO 3
Version or Model: 53-00466
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 53-00466
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 04546540684639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: MESH PLATE, ROUND, LARGE

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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Craniofacial fixation plate, non-bioabsorbable	A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

GMDN Preferred Term Name

GMDN Definition

Craniofacial fixation plate, non-bioabsorbable

A small, implantable sheet of firm material that is attached with screws to fractured craniofacial bone (including the maxilla and/or mandible), to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material cannot be chemically degraded or absorbed by natural body processes [includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre]. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.

FDA Product Code

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Product Code	Product Code Name
GWO	Plate, cranioplasty, preformed, alterable

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 Size Text, specify: Diameter: 57.0 Millimeter

Device Record Status

Public Device Record Key: 94506503-75b9-4f12-89aa-1752865ac642
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 23, 2015