Identity
- Trade Name
- SoundBite® Curving Tool 14 FDA UDI
- Generic Name
- Surgical probe/cannula bending tool FDA UDI
- Device Name
- The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU. FDA UDI
- Model / Reference
- 900-0001291 FDA UDI
- Description
- The SoundBite® Curving Tool 14 is used by the Physician to curve the tip of the active wire if desired. Its use is explained in the IFU. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 17540265105022 FDA UDI
- 510(k) Number
- K210839 FDA UDI
- FDA Product Code
- PDU FDA UDI
- GMDN Term
- Surgical probe/cannula bending tool FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.1250 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: Surgical probe/cannula bending tool
SoundBite® Curving Tool 14 by Soundbite Medical Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
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
- Soundbite Medical Solutions, Inc.
Sources (1)
- FDA UDI bfd220b7-3f2b-453a-b82c-fd28622409d5 35 fields · synced May 31, 2026