AccessGUDID - DEVICE: TAC PIN (10381780052821)

GUDID

Device Identifier (DI) Information

Brand Name: TAC PIN
Version or Model: 120015ND
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 120015ND
Company Name: NEWDEAL

Primary DI Number: 10381780052821
Issuing Agency: GS1
Commercial Distribution End Date: June 30, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 536935331 *Terms of Use

Device Description: The TAC PIN is a self tapping threaded wire. Its proximal part is fixed on a standard surgical power tool equipment and once the threaded wire is introduced and positioned as required, the surgeon cuts the protruding part at the bone surface. This pin is designed with a variable pitch, for a true and adapted compression. It is made out of titanium alloy, and it is delivered non sterile.

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":	Yes
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?
32854	Orthopaedic bone pin, non-bioabsorbable	A thin, implantable rod intended to be used for the stabilization of a bone fracture or bone grafts, or for an osteotomy or arthrodesis (internal and/or external fixation). It is typically drilled into bone and may be smooth or threaded, solid or cannulated, and/or semi-flexible. Also known as a Kirschner-wire (K-wire), it may in addition be intended to assist with the introduction of a surgical instrument and/or implant; it is not intended for implantation into the intramedullary canal (i.e., not a nail). It is made of a non-bioabsorbable material (e.g., stainless steel). Some designs may have a break-off shank and/or be coated to improve long-term fixation. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
JDW	PIN, FIXATION, THREADED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Special Storage Condition, Specify: Store in dry place.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.6mm diam. x 15mm length

Device Record Status

Public Device Record Key: cc4c07c3-ea8e-4e45-8695-3a15e5b3b849
Public Version Date: July 14, 2025
Public Version Number: 4
DI Record Publish Date: September 24, 2015