Guidewire ( Non-Threaded)

Basic Information

• Brand Name: Guidewire ( Non-Threaded)
• Primary DI: B922F005000100
• Version / Model: F005.0001
• Catalog Number: F005.0001
• Company Name: INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
• Labeler DUNS: 860396609
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-03-09
• Public Version: 1
• Public Version Date: 2026-03-17
• Public Version Status: New
• Public Device Record Key: 60391d52-b396-4b10-b2f9-21f65528093b

Device Description

Guidewire ( Non-Threaded)

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: Yes
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
63819	Spinal guidewire	A thin, non-implantable rod intended to guide the insertion of a cannulated orthopaedic implant (typically a screw) and/or surgical instrument (e.g., cannula, drill bit) during spinal surgery. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B922F005000100	HIBCC

Customer Contacts

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