Brella

Primary DI
00860009462229
Brand
Brella
Company
Candesant Biomedical, Inc.
Model
CB-1050
Catalog number
CB-1050
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
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
QVXSkin Patch For Treatment Of Hyperhidrosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QVXSkin Patch For Treatment Of HyperhidrosisGeneral, Plastic Surgery2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009462229PrimaryGS10
00860009462267Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009462229008600094622298600094622290860009462229
00860009462267008600094622678600094622670860009462267

GMDN Terms#

Term, Definition table
TermDefinition
AntiperspirantA 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
TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature10 Degrees Celsius40 Degrees Celsius
Special Storage Condition, Specify00Keep dry

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(223) 667-9328info@candesant.com

Regulatory Flags#

DUNS number
080125402
Device count
10
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009462236BrellaCB-1051CB-10512023-09-29
00860009462243BrellaCB-1052CB-10522023-09-29
00860009462205BrellaCB-1067CB-10672023-09-29
00860009462274BrellaCB-1051CB-10512023-09-29
00860009462281BrellaCB-1052CB-10522023-09-29
00860009462250BrellaCB-1053CB-10532023-09-26
00860009462298BrellaCB-1053CB-10532023-09-26
00860009462212BrellaCB-1068CB-10682023-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009462236BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462243BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462205BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462274BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462281BrellaCandesant Biomedical, Inc.QVX2023-09-29
00860009462250BrellaCandesant Biomedical, Inc.QVX2023-09-26
00860009462298BrellaCandesant Biomedical, Inc.QVX2023-09-26
00860009462212BrellaCandesant Biomedical, Inc.QVX2023-09-21