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THD Bandy
FDA UDIFDA 510(k)EUDAMEDClass II (US FDA UDI)
510(k) K093497
by Thd Spa
Identity
- Trade Name
- THD Bandy FDA UDI
- Generic Name
- Haemorrhoid ligation set FDA UDI
- Device Name
- THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger FDA UDI
- Model / Reference
- THD Bandy FDA UDI
- Description
- THD Bandy is a disposable suction ligator for the treatment of haemorrhoidal disease, ready to use. No cleaning or disinfection required. THD Disposable comes in single packing (single use), including ligator, 4 rings, and loading system. THD Bandy connects to a suction system, while it is possible to control the quality of aspirated tissue, around which the elastic band will be released by pulling the trigger FDA UDI
Identifiers
- Catalog Number
- 800079 FDA UDI
- Primary DI / UDI-DI
- 08033737710685 FDA UDI
- 510(k) Number
- K093497 FDA UDI
- FDA Product Code
- FHN FDA UDI
- GMDN Term
- Haemorrhoid ligation set 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 12.8 Millimeter FDA UDILength — 154 Millimeter FDA UDI
Category: Haemorrhoid ligation set
THD Bandy by Thd Spa — Class II — FDA_510K, MDR — listed in FDA GUDID, FDA 510(k), EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Haemorrhoid ligation set.
- Hemorrhoids Multiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Nexus Hemorroid Ligator — Inx Medical · Class II
- Topsuper Med — Topsuper Med, Inc. · Class II
- In-Sight — Micro-tech Usa · Class II
- Hemorrhoids Multiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Hemorrhoids Multiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Hemorrhoids Multiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
- Hemorrhoids Multiple Band Ligator Set — Micro-Tech (Nanjing) Co., Ltd. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Unknown
MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K093497 | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Unknown |
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Manufacturer
- Manufacturer
- Thd Spa
Sources (3)
- FDA UDI 1b2fee0a-f57d-476a-82fd-09312d3f5f11 61 fields · synced Jun 18, 2026
- FDA 510(k) K093497 1 fields · synced Jun 5, 2026
- EUDAMED 1 fields · synced Jun 2, 2026