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Smtp

FDA UDI

Class II (US FDA UDI)

by SMTP Medical Co., Ltd.

Identity

Trade Name
SMTP FDA UDI
Generic Name
Hard-tissue ultrasonic surgical system handpiece tip FDA UDI
Device Name
Hook-shaped scalpel with serrations (200mm,Curved) FDA UDI
Model / Reference
XDF02806518 FDA UDI
Description
Hook-shaped scalpel with serrations (200mm,Curved) FDA UDI

Identifiers

Primary DI / UDI-DI
06972603519996 FDA UDI
510(k) Number
K201274 FDA UDI
FDA Product Code
JDX FDA UDI
GMDN Term
Hard-tissue ultrasonic surgical system handpiece tip 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

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

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Hard-tissue ultrasonic surgical system handpiece tip

Smtp by SMTP Medical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Hard-tissue ultrasonic surgical system handpiece tip.

Cleared under the same submission

K201274 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
SMTP Medical Co., Ltd.

Sources (1)

  • FDA UDI f4db08a6-4b7d-425c-8c42-5fe19c8f210c 34 fields · synced Jun 6, 2026