AccessGUDID - DEVICE: Curaplex (00817617027630)

GUDID

Device Identifier (DI) Information

Brand Name: Curaplex
Version or Model: 1124-32400
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1124-32400
Company Name: BOUND TREE MEDICAL, LLC

Primary DI Number: 00817617027630
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 070556204 *Terms of Use

Device Description: Curaplex Triangular Bandage, Muslin 12/pk 20pk/cs 40 in x 40 in x 56 in, 2 safety pins

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?
12095	Arm immobilizer	A non-rigid device, usually made of a fabric, used to temporarily render the arm immovable, typically at the shoulder and elbow, to support healing of an injury or a surgical wound. This is a reusable 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: 07ff1c44-2a0c-4d1e-8d61-91720b0b0100
Public Version Date: April 07, 2023
Public Version Number: 1
DI Record Publish Date: March 30, 2023