Curativa Bay

Primary DI
00860007709470
Brand
Curativa Bay
Company
Curativa Bay, LLC
Model
WCHRX8
Device description
Rx INDICATIONS: The Prescription Use Curative Bay Wound Care Hydrogel Rx is indicated for the following uses: • Use with dermal irritation, sores, injuries and ulcers of dermal tissues. • Moistening and lubricating absorbent wound dressings and the wound bed and facilitate autolytic debridement of acute and chronic dermal lesions. • Management of partial or full thickness wounds such as 1st and 2nd degree burns, stage I - IV pressure ulcers, diabetic and stasis ulcers, abrasions and skin irritations, surgical wounds (donor and graft sites, incisions), trauma wounds, and various dermatoses including atopic dermatitis.
Published
2026-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FRODressing, Wound, DrugUnknownU

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860007709470PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860007709470008600077094708600077094700860007709470

GMDN Terms#

Term, Definition table
TermDefinition
Antimicrobial wound irrigation solutionA solution that includes an antimicrobial agent (e.g., sodium hypochlorite) intended to be used to irrigate and clean acute or chronic wounds, including first or second degree burns, to aid in autolytic debridement and to moisten a wound dressing(s), and to support natural healing. It is intended to be used in the home or healthcare facility. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
016206368
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003549179Curativa BayBCS82026-04-03
00860007709449Curativa BayWCS82026-04-03
00860007709456Curativa BayBCHOTC82026-03-26
00860007709494Curativa BayWCHOTC82026-03-26

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