N/A

Basic Information

• Brand Name: N/A
• Primary DI: 00885556605691
• Version / Model: 2921M
• Catalog Number: 2921M
• Company Name: Smith & Nephew, Inc.
• Labeler DUNS: 045483575
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2015-10-28
• Public Version: 4
• Public Version Date: 2023-09-07
• Public Version Status: Update
• Public Device Record Key: 7129aa07-81e3-4e49-9491-f2719c9708d5

Device Description

2ND GEN HOLDER LEG A SCOPIC

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: No
• Has Serial Number: Yes
• 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
FWZ	Accessories, operating-room, table (kit)	General, Plastic Surgery	878.4950	1

GMDN Terms

Code	Name	Definition	Implantable	Status
48139	Orthopaedic knee/leg holder liner	A sterile pad/cover designed to be placed between a patient's leg and an orthopaedic knee/leg holder, cushioning the leg to reduce the risk of damage of the skin/muscles/nerves during an orthopaedic procedure (e.g., arthroscopy, arthroplasty). It is typically made of disposable plastic material (e.g., a foam) with an appropriate shape and size to fit the holder. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00885556605691	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K830707	000