AccessGUDID - DEVICE: OrthoSolutions 'System26' Bone Screws (05055662955989)

GUDID

Device Identifier (DI) Information

Brand Name: OrthoSolutions 'System26' Bone Screws
Version or Model: OS900025-NS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: OS900025-NS
Company Name: ORTHO SOLUTIONS HOLDINGS LIMITED

Primary DI Number: 05055662955989
Issuing Agency: GS1
Commercial Distribution End Date: April 17, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 218648211 *Terms of Use

Device Description: K-WIRE FOR 3.0MM SCREW SINGLE TROCAR 1.0 X 70MM (CoCr)

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:	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?
66935	Orthopaedic intraoperative positioning pin, single-use	A nonimplantable device in the form of a thin rod intended to be drilled into bone to assist with the positioning of an implantable device and/or surgical instrument (e.g., fixation plate, drill guide) during an orthopaedic procedure. It is also referred to as a wire or temporary K-wire. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K163489	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
No Device Sizes

Device Record Status

Public Device Record Key: 5626acb9-f6bb-4153-a469-b427f2ef4a9f
Public Version Date: June 25, 2025
Public Version Number: 5
DI Record Publish Date: March 16, 2017