Home GUDID 00860009462274 Brella
Primary DI 00860009462274
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
OTC false
Sterile false
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 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00860009462236 Brella Candesant Biomedical, Inc. QVX 2023-09-29 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 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
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