AccessGUDID - DEVICE: K WIRE ROUND END PIN (B09911067160)

GUDID

Device Identifier (DI) Information

Brand Name: K WIRE ROUND END PIN
Version or Model: 1106-716
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: SONTEC INSTRUMENTS, INC.

Primary DI Number: B09911067160
Issuing Agency: HIBCC
Commercial Distribution End Date: September 22, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 040729840 *Terms of Use

Device Description: K WIRE PIN ROUND WITH ROUND END

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?
46865	Clavicle intramedullary nail-like rod	A rod intended to be implanted into the intramedullary canal of the clavicle bone for the fixation of a fracture(s) and/or treatment of malunion(s)/nonunion(s). Also referred to as a nail or pin, it may be straight, curved or bendable, and might be partially-threaded, stabilised with a bone screw, and/or incorporate expandable hook-like features for stabilisation; it is typically made of stainless steel. Devices intended to assist with stabilisation (e.g., a bone screw) may be included with the rod. This is a single-use device.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
HTY	Pin, Fixation, Smooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100736	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
Dry Heat Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 500 Millimeter
Width: 1.5 Millimeter

Device Record Status

Public Device Record Key: 310f8b91-87bc-40fb-8744-b485ff4ed77d
Public Version Date: February 06, 2025
Public Version Number: 8
DI Record Publish Date: September 23, 2016