Distal Humerus Fixation System

Basic Information

• Brand Name: Distal Humerus Fixation System
• Primary DI: 00842188119835
• Version / Model: GWDH-1.6
• Catalog Number: GWDH-1.6
• Company Name: TRIMED, INCORPORATED
• Labeler DUNS: 138041277
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-26
• Public Version: 3
• Public Version Date: 2023-07-31
• Public Version Status: Update
• Public Device Record Key: c5c5cd0a-ad57-412a-9f1f-0de932501357
• Distribution End Date: 2019-09-10

Device Description

Wire Guide Distal Humerus 1.6mm

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• 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: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXH	ORTHOPEDIC MANUAL SURGICAL INSTRUMENT	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
61929	Orthopaedic implant aiming/guiding block attachment tool	A manually-operated surgical instrument intended to be used to attach an orthopaedic implant aiming/guiding block to an implant (e.g., orthopaedic plate) to facilitate implantation. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00842188119835	GS1

Customer Contacts

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