Model: 02-00520
DI: 00810111227261
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-27
Current Version: 2026-05-05
Description
K-Wire
Sterilization
Method Types - Sterilization Method:
Moist Heat or Steam Sterilization
Device Sterile:
No
Sterilization Prior To Use:
Yes
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
3c008c1a-2b5a-4c0f-9232-a0ebf188abd6
Distribution Status:
In Commercial Distribution
DUNS Number:
054808082
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
00810111227261
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66935
Name: Orthopaedic intraoperative positioning pin, single-use
Definition:
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.
FDA Product Codes
HWE
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment