AccessGUDID - DEVICE: Universal Neuro 3 (07613327090758)

GUDID

Device Identifier (DI) Information

Brand Name: Universal Neuro 3
Version or Model: 56-15933
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 56-15933
Company Name: Stryker Leibinger GmbH & Co. KG

Primary DI Number: 07613327090758
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 316153956 *Terms of Use

Device Description: Screw, AXS, self-drilling

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?
46638	Craniofacial bone screw, non-bioabsorbable	A small, threaded rod with a slotted 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
HBW	FASTENER, PLATE, CRANIOPLASTY

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K151387	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: Diameter: 1.5 Millimeter
Length: 3.0 Millimeter

Device Record Status

Public Device Record Key: 71f8993d-27aa-4ad2-a0a5-a0b2ad49129d
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: September 24, 2015