FDA.reportPublic FDA data

revyve Antimicrobial Wound Gel

Primary DI
00628451217701
Brand
revyve Antimicrobial Wound Gel
Company
Kane Biotech Inc
Model
CWG030R
Device description
A white, odourless hydrogel that provides a moist wound environment conducive to wound healing. The gel provides preservative properties through an antimicrobial (PHMB) to help inhibit microbial colonization within the gel during shelf storage. Chronic wounds are known to contain non-viable tissue. The gel can facilitate debridement through a moist wound environment.
Published
2023-10-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FRODressing, Wound, Drug

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223259000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223259000coactiv+™ Antimicrobial Wound GelKane Biotech, Inc.2023-05-24FRO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01628451217700PackageGS136In Commercial Distribution
02628451217709PackageGS19In Commercial Distribution
03628451217708PackageGS118In Commercial Distribution
00628451217701PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
01628451217700016284512177001628451217700
02628451217709026284512177092628451217709
03628451217708036284512177083628451217708
00628451217701006284512177016284512177010628451217701

GMDN Terms#

Term, Definition table
TermDefinition
Wound hydrogel dressing, antimicrobialA wound covering typically made of cross-linked polymer gels in sheet form or an amorphous hydrating gel of various formulations, and that includes an antimicrobial agent, intended to promote wound healing by maintaining a moist wound environment; it may also facilitate wound debridement and/or absorb exudates in wounds that are minimally to moderately exudative. It may combine hydrogel with supplemental dressing materials (e.g., alginate, film backing), require the use of a secondary dressing, and/or provide a barrier impermeable to liquids and gases. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Weight28Gram

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-204-453-1301info@kanebiotech.com

Regulatory Flags#

DUNS number
201759276
Device count
1
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00628451217725revyve Antimicrobial Wound Gel SprayCWG142S2024-12-02
00628451217718revyve Antimicrobial Wound GelCWG090R2023-10-13
00628451217732revyve Antimicrobial Skin and Wound CleanserCWC118R2026-03-06

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