AccessGUDID - DEVICE: Architect (00854780005089)

GUDID

Device Identifier (DI) Information

Brand Name: Architect
Version or Model: HMT009M
Commercial Distribution Status: In Commercial Distribution
Catalog Number: HMT009M
Company Name: HARBOR MEDTECH, INC.

Primary DI Number: 00854780005089
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 016615914 *Terms of Use

Device Description: Collagen Wound Matrix

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47935	Skin xenograft	Skin 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGN	Wound Dressing With Animal-Derived Material(S)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 5 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Area/Surface Area: 9 Square centimeter

Device Record Status

Public Device Record Key: 1e395ac1-29d9-46d0-aeb8-782cf5a8c0a5
Public Version Date: April 02, 2025
Public Version Number: 1
DI Record Publish Date: March 25, 2025

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 949-446-9450
Email: jerrym@harbormedtech.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES