AccessGUDID - DEVICE: Guide Pin 10 mm (09321502015790)

GUDID

Device Identifier (DI) Information

Brand Name: Guide Pin 10 mm
Version or Model: 90794
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 90794
Company Name: Cochlear Bone Anchored Solutions AB

Primary DI Number: 09321502015790
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 559784736 *Terms of Use

Device Description: Laboratory component for prior generation Vistafix

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?
61467	General external orthopaedic fixation system implantation kit, single-use	A collection of non-sterile, manual surgical instruments intended to be used for the placement of an external orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It includes various instruments [e.g., retractors, rods, clamps, drills, pins/screws, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of external orthopaedic fixation system (i.e., non-dedicated); it does not include any implantable devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FZE	PROSTHESIS, NOSE, INTERNAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Store at room temperature

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 10 mm long guide pin
Length: 10 Millimeter

Device Record Status

Public Device Record Key: dd2d0544-479a-40f3-bda5-2964758dbc90
Public Version Date: December 21, 2020
Public Version Number: 5
DI Record Publish Date: June 07, 2017