AccessGUDID - DEVICE: Gold bar Ø2 x 100 mm (09321502014304)

GUDID

Device Identifier (DI) Information

Brand Name: Gold bar Ø2 x 100 mm
Version or Model: 90448
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90448
Company Name: Cochlear Bone Anchored Solutions AB

Primary DI Number: 09321502014304
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559784736 *Terms of Use

Device Description: Gold bar Ø2 x 100 mm

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:	No
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
FZE	PROSTHESIS, NOSE, INTERNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K945154	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: 100 mm long bar
Length: 100 Millimeter

Device Record Status

Public Device Record Key: fd450e33-3f8b-4ac2-a379-b1283c002c0a
Public Version Date: June 09, 2025
Public Version Number: 8
DI Record Publish Date: July 03, 2017