Regulatory Information

Maiden Biosciences, Inc., develops, manufactures and distributes its own brand, and private labels Topical Bovine Collagen Post Surgical Dressings under the following 510k Clearances.
Collagen Powder K030921
Collagen Sheets K040211

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: 2024

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

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Collagen Powder

Classification Name: | DRESSING, WOUND, COLLAGEN POWDER
Product Code: | KGN
Device Class: | Unclassified
Registered Establishment Name: | MAIDEN BIOSCIENCES
Registered Establishment Number: | 3012973796
Premarket Submission Number: | K030921
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