AccessGUDID - DEVICE: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM (05055662944761)

GUDID

Device Identifier (DI) Information

Brand Name: OXFORD ANKLE FUSION NAIL(AFN) SYSTEM
Version or Model: OS333013
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS333013
Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED

Primary DI Number: 05055662944761
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 218648211 *Terms of Use

Device Description: OXBRIDGE AFN DISPOSABLES - DRILLS / PIN & EXCHANGE TUBE

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
61781	Joint prosthesis implantation kit, single-use	A collection of surgical instruments intended to be used for cutting and forming bone to enable the implantation of a joint prosthesis. The instruments include various metallic and/or plastic disposable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks, trial prosthesis) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HSB	Rod, Fixation, Intramedullary And Accessories

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121575	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: f78c58f2-ca57-4bd3-b812-89737479726d
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: January 29, 2016