FDA.reportPublic FDA data

KeraStat Cream

Primary DI
B789P00210
Brand
KeraStat Cream
Company
Keranetics, Inc.
Model
00
Device description
Non-sterile, non-implantable wound dressing
Published
2021-04-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNDressing, Wound, Collagen

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192386000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192386000KeraStat CreamKeranetics2020-07-16KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B789P00211PackageHIBCC24In Commercial Distribution
B789P00210PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Skin semi-occlusive dressing, non-antimicrobialA substance (e.g., gel, ointment) intended to be topically applied to injured/diseased skin to expedite healing and re-epithelialization primarily through semi-occlusive properties which reduce moisture transmission from the skin to the environment by means of a physical barrier; it may also prevent abnormal scar formation and does not include an antimicrobial agent(s). It is intended for home/healthcare facility use to treat open skin wounds and/or conditions such as lacerations, burns, surgical wounds, radiation dermatitis, and inflammation. After application, this device cannot be reused.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature59 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
(336)725-0621info@keranetics.com

Regulatory Flags#

DUNS number
081252398
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B789P00100KeraStat Gel002021-04-20
B789P00200KeraStat Cream002021-04-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632441OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632465OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632601OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632618OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632632OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632649OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632663OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632694OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632731OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632748OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632755OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632762OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02