Triangular Bandage 96cm x 96cm x 136cm

Basic Information

• Brand Name: Triangular Bandage 96cm x 96cm x 136cm
• Primary DI: 04007418921404
• Version / Model: 92140
• Company Name: Hans Hepp GmbH & Co. KG
• Labeler DUNS: 315896217
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-25
• Public Version: 1
• Public Version Date: 2023-08-02
• Public Version Status: New
• Public Device Record Key: 311787a4-df7d-41e2-9554-c58df2be0691

Device Description

A non-sterile fabric and foam composite material in the form of a thick band intended to be used to produce a custom-made, figure-of-eight shaped arm sling. Suitable lengths are cut, typically from a roll or a dispenser box, and plastic clips used to fashion two loops, one for round the neck and the other for round a wrist (collar and cuff), to provide support for the arm. It consists of a foam core with a fabric covering and is typically used to immobilize forearm, elbow, humerus or shoulder injuries. This is a single-use device.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
ILI	Sling, Arm	Physical Medicine	890.3640	1

GMDN Terms

Code	Name	Definition	Implantable	Status
41048	Collar and cuff arm sling material	A non-sterile fabric and foam composite material in the form of a thick band intended to be used to produce a custom-made, figure-of-eight shaped arm sling. Suitable lengths are cut, typically from a roll or a dispenser box, and plastic clips used to fashion two loops, one for round the neck and the other for round a wrist (collar and cuff), to provide support for the arm. It consists of a foam core with a fabric covering and is typically used to immobilize forearm, elbow, humerus or shoulder injuries. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04007418921404	GS1