Aqua Liner L

Basic Information

• Brand Name: Aqua Liner L
• Primary DI: 04260652350045
• Version / Model: SA701.4L
• Catalog Number: SA701.4L
• Company Name: Romedis GmbH
• Labeler DUNS: 341502320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-10-11
• Public Version: 2
• Public Version Date: 2020-03-05
• Public Version Status: Update
• Public Device Record Key: dfa82c0e-85a1-4617-8a7a-1e9c3bab83c5

Device Description

Liner to be worn over residual limb

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: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ISS	Prosthesis, Thigh Socket, External Component	Physical Medicine	890.3420	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41536	External limb prosthesis socket liner	A flexible device designed to be fitted inside the socket of an external upper or lower limb prosthesis to form an interface between the socket and the residual limb; it is intended to enable the residual limb to optimally fit the socket by coupling the two together mechanically and/or by pressure differential. It may be made of various textile or synthetic polymer materials (e.g., silicone, thermoplastic elastomer, polyurethane).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260652350045	GS1