N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00817470009231
• Version / Model: 21-1004
• Catalog Number: 21-1004
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-08-30
• Public Version: 6
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: fa3a63ac-4e74-46bc-b972-4928d20d3daa
• Distribution End Date: 2022-03-17

Device Description

SUTURE CLAMP WITH TENSIOMETER

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: 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
56651	Tendon/ligament graft preparation station post	A component of a graft preparation station designed to be affixed to the station base to help position, clamp and tension a ligament and/or tendon graft being prepared for implantation. This device is typically made of high-grade stainless steel and is available in a variety of sizes and types such as adjustable or fixed graft posts, patellar tendon posts, soft tissue clamp posts, and tensioning posts. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00817470009231	GS1

Customer Contacts

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