AccessGUDID - DEVICE: UNIVERSAL NEURO 2 (37613154623939)

GUDID

Device Identifier (DI) Information

Brand Name: UNIVERSAL NEURO 2
Version or Model: 24-15004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 24-15004
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 37613154623939
Issuing Agency: GS1
Commercial Distribution End Date: February 28, 2025
Device Count: 4
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: NEURO SCREWS,CROSS-PIN,SELF-TAPPING

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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?
46638	Craniofacial bone screw, non-bioabsorbable	A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JEY	PLATE, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K031659	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Diameter: 1.5 Millimeter
Length: 4.0 Millimeter

Device Record Status

Public Device Record Key: 487ac185-4441-4c29-aeb9-a7f945c0e55d
Public Version Date: March 03, 2025
Public Version Number: 6
DI Record Publish Date: July 07, 2015