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Ssg10

FDA UDI

Class II (US FDA UDI)

by Saeshin Precision Co., Ltd.

Identity

Trade Name
SSG10 FDA UDI
Generic Name
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI
Device Name
BSG10/FUS12/MBP20SX/MBP20SX/TST40BN/TST40BN FDA UDI
Model / Reference
SSG10 #2 FDA UDI
Description
BSG10/FUS12/MBP20SX/MBP20SX/TST40BN/TST40BN FDA UDI

Identifiers

Primary DI / UDI-DI
08809260473713 FDA UDI
510(k) Number
K233153 FDA UDI
FDA Product Code
HBC FDA UDI
GMDN Term
Bone/joint surgical power tool motorized handpiece/set, electric, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.4360 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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Bone/joint surgical power tool motorized handpiece/set, electric, reusable

Ssg10 by Saeshin Precision Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone/joint surgical power tool motorized handpiece/set, electric, reusable.

Cleared under the same submission

K233153 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Saeshin Precision Co., Ltd.

Sources (1)

  • FDA UDI 384bcc19-39d1-46e3-8cd7-133e831789a8 34 fields · synced May 30, 2026