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Sinus Kit

FDA UDI

Class I (US FDA UDI)

by Shinhung MST Co., Ltd.

Identity

Trade Name
Sinus Kit FDA UDI
Generic Name
General surgical procedure kit, non-medicated, single-use FDA UDI
Device Name
Sinus Kit consists of drills & Instruments used for maxillary sinus elevation by crestal & lateral approach. FDA UDI
Model / Reference
SIDR2803 FDA UDI
Description
Sinus Kit consists of drills & Instruments used for maxillary sinus elevation by crestal & lateral approach. FDA UDI

Identifiers

Primary DI / UDI-DI
08806343906588 FDA UDI
FDA Product Code
EMJ 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

Sinus 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 50025fe4-ea86-4300-b6f3-27ab1bf8c7a1 35 fields · synced May 31, 2026