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THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S FDA UDI
- Generic Name
- Electrosurgical handpiece, single-use FDA UDI
- Device Name
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S FDA UDI
- Model / Reference
- TB-0535FCS FDA UDI
- Description
- THUNDERBEAT 5 mm,35 cm,Front-actuated Grip Type S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04953170409677 FDA UDI
- 510(k) Number
- K211838 FDA UDI
- FDA Product Code
- LFL FDA UDIGEI FDA UDI
- GMDN Term
- Electrosurgical handpiece, single-use FDA UDI
Classification
- Device Class
- U FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
No
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Electrosurgical handpiece, single-use
THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S by Olympus Medical Systems Corporation — Class U — FDA UDI — listed in FDA GUDID
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Cleared under the same submission
K211838 also covers:
- SONICBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 10 cm, Inline Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 20 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 35 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Front-actuated Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT 5 mm, 45 cm, Pistol Grip — Olympus Medical Systems Corporation
- SONICBEAT Footswitch Connector — Olympus Medical Systems Corporation
- SONICBEAT Transducer — Olympus Medical Systems Corporation
- THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S — Olympus Medical Systems Corporation
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 U | Pending data |
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Manufacturer
- Manufacturer
- Olympus Medical Systems Corporation
Sources (1)
- FDA UDI 206e6e54-334f-455a-b074-ea8b158ca936 35 fields · synced May 30, 2026