FDA.reportPublic FDA data

Architect Px

Primary DI
00854780005126
Brand
Architect Px
Company
HARBOR MEDTECH, INC.
Model
HMT009MPx
Catalog number
HMT009MPx
Device description
Collagen Wound Matrix
Published
2025-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
00854780005126PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00854780005126008547800051268547800051260854780005126

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 Area9Square centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature5 Degrees Fahrenheit25 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
949-446-9450jerrym@harbormedtech.com

Regulatory Flags#

DUNS number
016615914
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
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
00854780005539Architect FxHMT036FxHMT036Fx2026-02-24
00854780005546Architect FxHMT100FxHMT100Fx2026-02-24
00854780005553Architect FxHMT150FxHMT150Fx2026-02-24
00854780005560Architect FxHMT016FxHMT016Fx2026-02-24
00854780005577Architect FxHMT016FFxHMT016FFx2026-02-24
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
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02
00850084084034CURCOFR TECH, LLCKGN2026-06-02
00850084084041CURCOFR TECH, LLCKGN2026-06-02
00850084084058CURCOFR TECH, LLCKGN2026-06-02
00850084084065CURCOFR TECH, LLCKGN2026-06-02
00850084084072CURCOFR TECH, LLCKGN2026-06-02
00850084084089CURCOFR TECH, LLCKGN2026-06-02
00714196003317DermaCol 100 Gel 1oz TubeSion Brands LLCKGN2026-06-01
07610221017737Derma-Gide®Geistlich Pharma AGKGN2026-06-01
00813954028385collateneCOLLAGEN MATRIX, INC.KGN2026-05-05
10840330705858ProCureTwin Med, LLCKGN2026-05-04
10840330705834ProCureTwin Med, LLCKGN2026-04-28
10840330705841ProCureTwin Med, LLCKGN2026-04-28
00812593023119NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023126NeoForm AWCBiogennix, LLCKGN2026-04-27
00812593023072NeoSurg Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023089ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023096ossFX Surgical CollagenBiogennix, LLCKGN2026-04-22
00812593023102ColSyntekBiogennix, LLCKGN2026-04-22
10885632434280HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
10885632434297HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-04-16
00324357900012Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00324357900777Zeni MedicalFocus Health Group, Inc.KGN2026-04-13
00812593023058Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023065Agilon Surgical Collagen +Biogennix, LLCKGN2026-04-02
00812593023034CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
00812593023041CuraSurg Surgical CollagenBiogennix, LLCKGN2026-04-01
10885632434273HalyardOWENS & MINOR DISTRIBUTION, INC.KGN2026-03-31