| Primary Device ID | 00854780005515 |
| NIH Device Record Key | 43f08814-16bb-4965-846d-e5f42256a819 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Architect Fx |
| Version Model Number | HMT100FFx |
| Catalog Number | HMT100FFx |
| Company DUNS | 016615914 |
| Company Name | HARBOR MEDTECH, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com | |
| Phone | (888) 346-9802 |
| complaints@stimlabs.com |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Area/Surface Area | 100 Square centimeter |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Storage Environment Temperature | Between 5 Degrees Celsius and 25 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00854780005515 [Primary] |
| KGN | Wound Dressing With Animal-Derived Material(S) |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-05 |
| Device Publish Date | 2026-02-25 |
| 00854780005515 - Architect Fx | 2026-03-05Collagen Wound Matrix |
| 00854780005515 - Architect Fx | 2026-03-05 Collagen Wound Matrix |
| 00854780005126 - Architect Px | 2025-10-06 Collagen Wound Matrix |
| 00854780005232 - Architect Px | 2025-10-06 Collagen Wound Matrix |
| 00854780005249 - Architect Px | 2025-10-06 Collagen Wound Matrix |
| 00854780005256 - Architect Px | 2025-10-06 Collagen Wound Matrix |
| 00854780005263 - Architect Px | 2025-10-06 Collagen Wound Matrix |
| 00854780005270 - Architect Px | 2025-10-06 Collagen Wound Matrix |
| 00854780005287 - Architect Px | 2025-10-06 Collagen Wound Matrix |