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Surgical Kit

FDA UDI

Class I (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name
Surgical Kit FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
These instruments are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely. FDA UDI
Model / Reference
H09D00L FDA UDI
Description
These instruments are surgical tools that are used to expect the direction and place of implant, to measure the drilling hole depth and gingival height for selecting abutments according to gingival heights and to insert the implant in prepared implant site after drilling for preparation of the site of dental implants, to successful Crestal Approach Sinus operation by cutting sinus floor promptly and lifting up the Sinus Membrane safely. FDA UDI

Identifiers

Primary DI / UDI-DI
08806343902115 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
Dry Heat Sterilization FDA UDI

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

Surgical 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 df564cb5-7ecd-4aed-b4c1-3c0bc1b250ce 35 fields · synced Jun 8, 2026