K-Wire w. trocar/round end 0.89mm/229mm, 6 pcs./unit

Basic Information

• Brand Name: K-Wire w. trocar/round end 0.89mm/229mm, 6 pcs./unit
• Primary DI: EMAHKM711510
• Version / Model: KM71-151
• Catalog Number: KM71-151
• Company Name: mahe medical gmbh
• Labeler DUNS: 342243334
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2016-06-10
• Public Version: 3
• Public Version Date: 2024-02-19
• Public Version Status: Update
• Public Device Record Key: d950ee62-e9d5-4d5f-b219-fa16b5239897

Device Description

K-Wire w. trocar/round end 0.89mm/229mm, 6 pcs./unit

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
HTY	PIN, FIXATION, SMOOTH	Orthopedic	888.3040	2

GMDN Terms

Code	Name	Definition	Implantable	Status
35685	Orthopaedic bone wire	A wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	EMAHKM711511	HIBCC		1	In Commercial Distribution
Primary	EMAHKM711510	HIBCC
Unit of Use	EMAHKM711512	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Device Sizes

Type	Value	Unit	Text
Length	229.0	Millimeter
Outer Diameter	0.89	Millimeter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: cool, dry & dark place
• Type: Storage Environment Temperature
• Temperature Range: 10 – 28 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 50 Percent (%) Relative Humidity