Regulatory Information

Maiden Biosciences, Inc., distributes its own brand of Topical Bovine Collagen Post Surgical Dressings.

NAICS Code | Name | NAICS Exception | Size Standard | Small Business |
325412 | Pharmaceutical Preparation Manufacturing   1250 | Y
339112 | Surgical and Medical Instrument Manufacturing   1000 | Y
423450 | Medical, Dental, and Hospital Equipment and Supplies Merchant Wholesalers    500 | Y

MAIDEN BIOSCIENCES, INC. DUNS 065980259
Commercial and Government Entity (CAGE) CAGE 8N9C9
Primary Product Service Code is PSC 6515 – Medical surgical supplies
Maiden TIN  81-2512175

 

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FDA Registrations

Establishment:
MAIDEN BIOSCIENCES, INC.
101 Lakeforest Blvd., Suite 390
Gaithersburg, MD 20877
Registration Number: 3012973796
FEI Number*: 3012973796
Status: Active
Date Of Registration Status: 2025

Owner/Operator:
Maiden Biosciences, Inc.
101 Lakeforest Blvd., Suite 390
Gaithersburg, MD 20877
Owner/Operator Number: 10052710
 

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Collagen Dressings

Classification Name: | DRESSING, WOUND, COLLAGEN
Product Code: | KGN
Device Class: | Unclassified
Registered Establishment Name: | MAIDEN BIOSCIENCES
Registered Establishment Number: | 3012973796
Owner/Operator: | Maiden Biosciences, Inc.
Owner/Operator Number: | 10052710
Establishment Operations: | Specification Developer
 

Device | Dressing, Wound, Collagen

Review Panel | General & Plastic Surgery
Product Code | KGN
Premarket Review | Surgical and Infection Control Devices (OHT4)
Infection Control and Plastic Surgery Devices (DHT4B)
Unclassified Reason | Pre-Amendment
Submission Type | 510(k)
Device Class | Unclassified
GMP Exempt? | No
Summary Malfunction
Reporting | Ineligible
Implanted Device? | Yes
Life-Sustain/Support Device? | No
Third Party Review | Not Third Party Eligible