Device
K-wire Guide, 2.0mm
Manufacturer
Pace Surgical, Inc.
Model: PS2-2400020 Catalog: PS2-2400020 DI: 00810211044126 Status: New MRI: Labeling does not contain MRI Safety Information Single-use: No Rx: Yes OTC: No
First Published: 2026-04-27 Current Version: 2026-05-05
Description
K-wire Guide, 2.0mm
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: 22c9449f-4030-4539-856c-219d5228ac5e
Distribution Status: In Commercial Distribution
DUNS Number: 119302878
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: No
Donation ID Number Tracked: No
Labeled Contains NRL: No
Labeled No NRL: No
Identifiers
Device ID: 00810211044126
Type: Primary
Issuing Agency: GS1
GMDN
Code: 66934
Name: Orthopaedic intraoperative positioning pin, reusable
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 reusable device.
FDA Product Codes
FZX
Guide, Surgical, Instrument