AccessGUDID - DEVICE: Triangular Bandage 96cm x 96cm x 136cm (04007418921459)

GUDID

Device Identifier (DI) Information

Brand Name: Triangular Bandage 96cm x 96cm x 136cm
Version or Model: 92145
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Hans Hepp GmbH & Co. KG

Primary DI Number: 04007418921459
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315896217 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ILI	Sling, Arm

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0705a313-f23c-4e3f-8db0-b23f49182884
Public Version Date: August 02, 2023
Public Version Number: 1
DI Record Publish Date: July 25, 2023