Identity
- Trade Name
- SMTP FDA UDI
- Generic Name
- Ultrasonic surgical system torque wrench, reusable FDA UDI
- Device Name
- Torque wrench FDA UDI
- Model / Reference
- XDF07801N FDA UDI
- Description
- Torque wrench FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06972603519057 FDA UDI
- 510(k) Number
- K201274 FDA UDI
- FDA Product Code
- JDX FDA UDI
- GMDN Term
- Ultrasonic surgical system torque wrench, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.4580 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
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Ultrasonic surgical system torque wrench, reusable
Smtp by SMTP Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201274 also covers:
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
- SMTP — SMTP Medical Co., Ltd.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SMTP Medical Co., Ltd.
Sources (1)
- FDA UDI 50eee3a5-20de-49e4-b766-2c9609fe0ff1 34 fields · synced May 30, 2026