Sleeve heavy-duty1

Basic Information

• Brand Name: Sleeve heavy-duty1
• Primary DI: 04260652350106
• Version / Model: SA900
• Catalog Number: SA9001H
• Company Name: Romedis GmbH
• Labeler DUNS: 341502320
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-05-25
• Public Version: 1
• Public Version Date: 2020-06-02
• Public Version Status: New
• Public Device Record Key: d6ade1cb-5e0f-44ca-b191-79e84388b263

Device Description

sleeve worn over residual limb/socket

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
44595	Prosthesis suspension system	A group of devices used to hold/fasten a prosthesis to the body. The devices include locking pins, belts, silicone or neoprene sleeves, wedges, clamps, and suction sockets.	No	Obsolete

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04260652350106	GS1