AccessGUDID - DEVICE: STERILE TRAC SYSTEM 12 PACK (00841036198688)

GUDID

Device Identifier (DI) Information

Brand Name: STERILE TRAC SYSTEM 12 PACK
Version or Model: SP-STA-1021-12
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: SP-STA-1021-12
Company Name: BIOMET MICROFIXATION, INC

Primary DI Number: 00841036198688
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 046189866 *Terms of Use

Device Description: No description.

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 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
15749	Cranial bur hole cover	A sterile device used to cover or to plug holes drilled into the skull during surgery and to reattach cranial bone removed during the intervention. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JEY	PLATE, BONE
HRS	PLATE, FIXATION, BONE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K972322	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
No Device Sizes

Device Record Status

Public Device Record Key: aba42c73-d9a7-4f23-8440-a7af57707026
Public Version Date: September 18, 2023
Public Version Number: 5
DI Record Publish Date: October 01, 2015