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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
Ultrasonic surgical system handpiece cooling sleeve FDA UDI
Device Name
Liquid-flow sleeve (hard) FDA UDI
Model / Reference
XDF0980115 FDA UDI
Description
Liquid-flow sleeve (hard) FDA UDI

Identifiers

Primary DI / UDI-DI
06972603519040 FDA UDI
510(k) Number
K201274 FDA UDI
FDA Product Code
JDX FDA UDI
GMDN Term
Ultrasonic surgical system handpiece cooling sleeve 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Ultrasonic surgical system handpiece cooling sleeve

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

Similar devices

Also classified as Ultrasonic surgical system handpiece cooling sleeve.

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 f6e85d4f-fdb4-4cfd-a493-d3d8109ee245 34 fields · synced May 30, 2026