endophix

Basic Information

• Brand Name: endophix
• Primary DI: 06974940306246
• Version / Model: MS-3213-03S
• Company Name: Suzhou Endophix Co., Ltd.
• Labeler DUNS: 620899345
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-05
• Public Version: 1
• Public Version Date: 2025-12-15
• Public Version Status: New
• Public Device Record Key: cf1f7e8b-5639-4194-8c9a-aa8778b5d180

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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
HXI	Passer, Wire, Orthopedic	Orthopedic	888.4540	1

GMDN Terms

Code	Name	Definition	Implantable	Status
42595	Soft-tissue surgical hook, reusable	A hand-held, shaft-like, manual surgical instrument designed for hooking and applying traction to specific soft-tissues of interest (e.g., skin, vessel, organ, and/or duct), to facilitate surgical intervention; it is not dedicated to separating or drawing aside the margins of a surgical wound/incision (i.e., not a blade-style retractor). The device includes a handle and tapers towards the distal end to form a slender hook/parallel hooks. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06974940306246	GS1