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S-Guide Kit

FDA UDI

Class I (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name
S-Guide Kit FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Keyless, precise, open guided surgery kit, designed to allow for more accurate, efficient and safe surgery with minimal error and drill heating. FDA UDI
Model / Reference
SSGW50C FDA UDI
Description
Keyless, precise, open guided surgery kit, designed to allow for more accurate, efficient and safe surgery with minimal error and drill heating. FDA UDI

Identifiers

Primary DI / UDI-DI
08806343921178 FDA UDI
FDA Product Code
EJB FDA UDI
GMDN Term
General surgical procedure kit, non-medicated, single-use FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
872.4565 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

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

Category: General surgical procedure kit, non-medicated, single-use

S-Guide Kit by Shinhung MST Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General surgical procedure kit, non-medicated, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Shinhung MST Co., Ltd.

Sources (1)

  • FDA UDI 4f9b7a43-5b5b-4294-937a-3d1afaa32290 35 fields · synced May 31, 2026