Identity
- Trade Name
- BR Surgical, LLC FDA UDI
- Generic Name
- Haemorrhoid ligator FDA UDI
- Device Name
- GOWEN Suction Hemorrhoid Ligator, style 3, with loading cone & suction stop, Ø 10mm suction head, angled down 30° FDA UDI
- Model / Reference
- BR68-45800 FDA UDI
- Description
- GOWEN Suction Hemorrhoid Ligator, style 3, with loading cone & suction stop, Ø 10mm suction head, angled down 30° FDA UDI
Identifiers
- Catalog Number
- BR68-45800 FDA UDI
- Primary DI / UDI-DI
- 00840183500566 FDA UDI
- FDA Product Code
- FHN FDA UDI
- GMDN Term
- Haemorrhoid ligator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haemorrhoid ligator
BR Surgical, LLC by Br Surgical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Haemorrhoid ligator.
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- ESI — FTT MEDICAL, INC. · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class I
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Br Surgical Llc
Sources (1)
- FDA UDI fb62bb42-135b-4b30-9bcb-754783623aac 35 fields · synced Jun 8, 2026