AccessGUDID - DEVICE: TSP HIP FX PLATING SYSTEMGUIDE PIN DRIVER, 3.0MM (00887868130151)

GUDID

Device Identifier (DI) Information

Brand Name: TSP HIP FX PLATING SYSTEMGUIDE PIN DRIVER, 3.0MM
Version or Model: 14-451503
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 14-451503
Company Name: Biomet Orthopedics, LLC

Primary DI Number: 00887868130151
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 129278169 *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?
46165	Orthopaedic guidewire, reusable	A thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KTT	APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
JDO	DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140018	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: 7ebb4d75-a2a7-41c5-9465-e80a38c8a601
Public Version Date: May 30, 2025
Public Version Number: 7
DI Record Publish Date: September 26, 2016