AccessGUDID - DEVICE: Brella (00860009462229)

GUDID

Device Identifier (DI) Information

Brand Name: Brella
Version or Model: CB-1050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CB-1050
Company Name: Candesant Biomedical, Inc.

Primary DI Number: 00860009462229
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 080125402 *Terms of Use

Device Description: Ten count (CB-1067) a skin patch for the treatment of hyperhidrosis in a prescription topical patch that utilizes a chemical reaction to generate thermal energy in situ for treatment of hyperhidrosis

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):	Yes
Over the Counter (OTC):	No
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?
61257	Antiperspirant	A substance (e.g., gel, solution, cream) intended to be topically applied to the skin (e.g., underarms, hands, feet) to prevent sweating, typically as a treatment for hyperhidrosis. It includes aluminium compounds (e.g., aluminium chloride hexahydrate) and is intended to block the sweat pores through formation of a gel. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QVX	Skin Patch For Treatment Of Hyperhidrosis

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No 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
Handling Environment Temperature: between 10 and 40 Degrees Celsius
Special Storage Condition, Specify: Keep dry

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: Oval shape with width 2.75" and length 5"

Device Record Status

Public Device Record Key: 0762458b-9885-42a1-9a44-2e07d09fd3c9
Public Version Date: October 09, 2023
Public Version Number: 1
DI Record Publish Date: September 29, 2023