AccessGUDID - DEVICE: Cravat/Triangular Bandage, Box 50 (00850013417094)

GUDID

Device Identifier (DI) Information

Brand Name: Cravat/Triangular Bandage, Box 50
Version or Model: 05001-50
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 05001-50
Company Name: Altitude Technologies Inc.

Primary DI Number: 00850013417094
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 621904622 *Terms of Use

Device Description: Sling, Arm

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):	No
Kit:	Yes
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?
13622	Suspension arm sling	A non-sterile hanging triangular-shaped loop, suspended from a patient's neck/shoulder, typically intended to support an injured arm and limit its range of motion, or immobilize it, during the period of healing. It is typically fashioned from a single sheet of textile material by tying/fastening the ends. This is a reusable device intended for single-patient use.	Obsolete	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: 6ca732bc-8c3e-43ae-aa34-bf735eaa6a87
Public Version Date: June 13, 2023
Public Version Number: 2
DI Record Publish Date: May 18, 2020