FDA.reportPublic FDA data

Architect Fx

Primary DI
00854780005539
Brand
Architect Fx
Company
HARBOR MEDTECH, INC.
Model
HMT036Fx
Catalog number
HMT036Fx
Device description
Collagen Wound Matrix
Published
2026-02-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00854780005539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854780005539008547800055398547800055390854780005539

GMDN Terms#

Term, Definition table
TermDefinition
Skin xenograftSkin tissue intended for transplantation that is harvested from an animal donor (e.g., porcine source) and implanted in a human recipient. The tissue is used to temporarily replace skin (for a few days) typically lost due to extensive wounds and burns, when sufficient tissue from the patient or skin banks is not available, to cover and protect the lesions and reduce fluid loss. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Area/Surface Area36Square centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Celsius25 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
(888) 346-9802complaints@stimlabs.com

Regulatory Flags#

DUNS number
016615914
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00854780005515Architect FxHMT100FFxHMT100FFx2026-02-25
00854780005409Architect FxHMT009FFxHMT009FFx2026-02-24
00854780005447Architect FxHMT016MFxHMT016MFx2026-02-24
00854780005454Architect FxHMT036MFxHMT036MFx2026-02-24
00854780005461Architect FxHMT100MFxHMT100MFx2026-02-24
00854780005478Architect FxHMT150FFxHMT150FFx2026-02-24
00854780005485Architect FxHMT150MFxHMT150MFx2026-02-24
00854780005492Architect FxHMT009MFxHMT009MFx2026-02-24
00854780005508Architect FxHMT036FFxHMT036FFx2026-02-24
00854780005522Architect FxHMT009FxHMT009Fx2026-02-24
00854780005546Architect FxHMT100FxHMT100Fx2026-02-24
00854780005553Architect FxHMT150FxHMT150Fx2026-02-24
00854780005560Architect FxHMT016FxHMT016Fx2026-02-24
00854780005577Architect FxHMT016FFxHMT016FFx2026-02-24
00854780005126Architect PxHMT009MPxHMT009MPx2025-09-26
00854780005232Architect PxHMT004Px2025-09-26
00854780005249Architect PxHMT009PxHMT009Px2025-09-26
00854780005256Architect PxHMT016Px2025-09-26
00854780005263Architect PxHMT100PxHMT100Px2025-09-26
00854780005270Architect PxHMT016FPxHMT016FPx2025-09-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013117504DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00860013117511DermiSphere™ hDRTFesariustherapeutics Inc.KGN2026-09-24
00850016008190BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008206BaseMEMViscus Biologics LLCKGN2026-09-21
00850016008220BaseMEMViscus Biologics LLCKGN2026-09-21
05694310969468MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969482MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969505MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969529MariGen® CompactKERECIS hf.KGN2026-09-18
05694310969543SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969567SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969581SurgiClose® CompactKERECIS hf.KGN2026-09-18
05694310969604SurgiClose® CompactKERECIS hf.KGN2026-09-18
00841277111262Novera RenewHarps USA, Inc.KGN2026-08-26
00850086458062MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00860012016679MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-08-21
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632410OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632427OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632434OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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