Home GUDID 00860009462236 Brella
Primary DI 00860009462236
Brand Brella
Company Candesant Biomedical, Inc.
Model CB-1051
Catalog number CB-1051
Device description Two 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
Published 2023-09-29
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name QVX Skin Patch For Treatment Of Hyperhidrosis
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QVX Skin Patch For Treatment Of Hyperhidrosis General, Plastic Surgery 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00860009462236 Primary GS1 0 00860009462274 Unit of Use GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00860009462236 00860009462236 860009462236 0860009462236 00860009462274 00860009462274 860009462274 0860009462274
GMDN Terms# Term, Definition table Term Definition 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.
Device Sizes# Type, Value, Unit table Type Value Unit Device Size Text, specify 0
Storage And Handling# Type, Low, High table Type Low High Condition Handling Environment Temperature 10 Degrees Celsius 40 Degrees Celsius Special Storage Condition, Specify 0 0 Keep dry
Regulatory Flags# DUNS number 080125402 Device count 2 Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860009462243 Brella Candesant Biomedical, Inc. QVX 2023-09-29 00860009462205 Brella Candesant Biomedical, Inc. QVX 2023-09-29 00860009462229 Brella Candesant Biomedical, Inc. QVX 2023-09-29 00860009462274 Brella Candesant Biomedical, Inc. QVX 2023-09-29 00860009462281 Brella Candesant Biomedical, Inc. QVX 2023-09-29 00860009462250 Brella Candesant Biomedical, Inc. QVX 2023-09-26 00860009462298 Brella Candesant Biomedical, Inc. QVX 2023-09-26 00860009462212 Brella Candesant Biomedical, Inc. QVX 2023-09-21