Architect Fx HMT100FFx

GUDID 00854780005515

Collagen Wound Matrix

HARBOR MEDTECH, INC.

Skin xenograft
Primary Device ID00854780005515
NIH Device Record Key43f08814-16bb-4965-846d-e5f42256a819
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchitect Fx
Version Model NumberHMT100FFx
Catalog NumberHMT100FFx
Company DUNS016615914
Company NameHARBOR MEDTECH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com
Phone(888) 346-9802
Emailcomplaints@stimlabs.com

Device Dimensions

Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter
Area/Surface Area100 Square centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius
Storage Environment TemperatureBetween 5 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100854780005515 [Primary]

FDA Product Code

KGNWound Dressing With Animal-Derived Material(S)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-05
Device Publish Date2026-02-25

Devices Manufactured by HARBOR MEDTECH, INC.

00854780005515 - Architect Fx2026-03-05Collagen Wound Matrix
00854780005515 - Architect Fx2026-03-05 Collagen Wound Matrix
00854780005126 - Architect Px2025-10-06 Collagen Wound Matrix
00854780005232 - Architect Px2025-10-06 Collagen Wound Matrix
00854780005249 - Architect Px2025-10-06 Collagen Wound Matrix
00854780005256 - Architect Px2025-10-06 Collagen Wound Matrix
00854780005263 - Architect Px2025-10-06 Collagen Wound Matrix
00854780005270 - Architect Px2025-10-06 Collagen Wound Matrix
00854780005287 - Architect Px2025-10-06 Collagen Wound Matrix

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