AccessGUDID - DEVICE: Fuse ULTRA FOOT PLATING SYSTEM (B565OS20132090)

GUDID

Device Identifier (DI) Information

Brand Name: Fuse ULTRA FOOT PLATING SYSTEM
Version or Model: OS2013209
Commercial Distribution Status: In Commercial Distribution
Catalog Number: OS2013209
Company Name: CPM Medical Consultants, LLC

Primary DI Number: B565OS20132090
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 017138000 *Terms of Use

Device Description: 2.0 MM K-WIRE, 9 INCH LENGTH, TROCAR-BLUNT

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?
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
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141784	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: 1d599b13-72a0-40d4-962c-213ba56c50fc
Public Version Date: June 06, 2025
Public Version Number: 1
DI Record Publish Date: May 29, 2025