AccessGUDID - DEVICE: V2 TRIVERSE FIN THIN PUNCH (09348215127633)

GUDID

Device Identifier (DI) Information

Brand Name: V2 TRIVERSE FIN THIN PUNCH
Version or Model: 122-22-6102
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: SIGNATURE ORTHOPAEDICS PTY LTD

Primary DI Number: 09348215127633
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 751993028 *Terms of Use

Device Description: No description.

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?
37837	Orthopaedic osteotome blade, reusable	A sharp component of an orthopaedic osteotome intended to be attached to a dedicated handle (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is typically flat or curved (concave) in design and bevelled on one or both sides; it is made of high-grade stainless steel. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HWM	Osteotome

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222380	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: 02f170ce-c31e-482b-a7eb-65084a39c923
Public Version Date: April 17, 2025
Public Version Number: 1
DI Record Publish Date: April 09, 2025