Orthodontic Screw Removal Tool

FDA UDIEUDAMED

Class I (US FDA UDI)

Ref HSRT18HRef HSRT14H

by OSSTEM IMPLANT Co., Ltd.

Identity

Trade Name: Orthodontic Screw Removal Tool EUDAMEDFDA UDI
Generic Name: Surgical screwdriver, single-use FDA UDI
Device Name: Surgical Instrument System EUDAMED
Model / Reference: HSRT18H EUDAMEDFDA UDI
HSRT14H EUDAMEDFDA UDI
OSRT18H FDA UDI

Identifiers

Primary DI / UDI-DI: 08800209375105 EUDAMEDFDA UDI
08800209375068 EUDAMEDFDA UDI
08800121767385 FDA UDI
Basic UDI-DI: 88000406CLASSIBS25V EUDAMED
FDA Product Code: NDP FDA UDI
EMDN Code: Q010599 DENTAL INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
GMDN Term: Surgical screwdriver, single-use FDA UDI

Classification

Device Class: Class I EUDAMEDFDA UDI
Regulation Number: 872.3980 FDA UDI
Market of Registration: Czechia EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

Yes

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical screwdriver, single-use

Orthodontic Screw Removal Tool by OSSTEM IMPLANT Co., Ltd. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Also classified as Surgical screwdriver, single-use.

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OPERACE — PB SWISS TOOLS AG · Class I

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class I	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class I	Pending data

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Manufacturer

Manufacturer: OSSTEM IMPLANT Co., Ltd.

Sources (5)

FDA UDI a7177729-b908-481c-83c6-014ce30a1223 32 fields · synced Jul 20, 2026
FDA UDI 8be55b35-e5fb-4abc-825a-ebea149fc885 32 fields · synced May 29, 2026
FDA UDI 1d4606d7-728f-463f-b76b-205c190f22fe 32 fields · synced May 30, 2026
EUDAMED 8b42eb9a-94db-4d67-a060-dc8c2ea6ce56 61 fields · synced Jul 13, 2026
EUDAMED bcdb7016-5f08-40b6-ab04-dc994d506aad 61 fields · synced Jul 20, 2026