Architect Px HMT016MPx

GUDID 00854780005287

Collagen Wound Matrix

HARBOR MEDTECH, INC.

Skin xenograft
Primary Device ID00854780005287
NIH Device Record Keyd4ad6ec9-40c8-4643-8acf-4a722d29e26d
Commercial Distribution StatusIn Commercial Distribution
Brand NameArchitect Px
Version Model NumberHMT016MPx
Catalog NumberHMT016MPx
Company DUNS016615914
Company NameHARBOR MEDTECH, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com
Phone949-446-9450
Emailjerrym@harbormedtech.com

Device Dimensions

Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter
Area/Surface Area16 Square centimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit
Storage Environment TemperatureBetween 5 Degrees Fahrenheit and 25 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
GS100854780005287 [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 Date2025-10-06
Device Publish Date2025-09-26

On-Brand Devices [Architect Px]

00854780005430Collagen Wound Matrix
00854780005423Collagen Wound Matrix
00854780005416Collagen Wound Matrix
00854780005393Collagen Wound Matrix
00854780005386Collagen Wound Matrix
00854780005379Collagen Wound Matrix
00854780005362Collagen Wound Matrix
00854780005355Collagen Wound Matrix
00854780005348Collagen Wound Matrix
00854780005331Collagen Wound Matrix
00854780005324Collagen Wound Matrix
00854780005317Collagen Wound Matrix
00854780005300Collagen Wound Matrix
00854780005294Collagen Wound Matrix
00854780005287Collagen Wound Matrix
00854780005270Collagen Wound Matrix
00854780005263Collagen Wound Matrix
00854780005256Collagen Wound Matrix
00854780005249Collagen Wound Matrix
00854780005232Collagen Wound Matrix
00854780005126Collagen Wound Matrix

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