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KS Guide OKGRL

by OSSTEM IMPLANT Co., Ltd.

Ref OKGRL

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Overview

The KS Guide is a reusable, tubular surgical drill guide designed for surgeons to simultaneously place, angle, and guide rotating surgical drills on hard tissue. It features guiding holes, serrations for firm placement, and may have graduations along its length.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406CLASSIBS25V Basic UDI-DI 08809892362072UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809892362072 UDI-DI Date1 Nov 2023ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
KS Guide
Generic Name
Surgical drill guide, reusable
Device Name
Instrument System
Model / Reference
OKGRL
Primary DI / UDI-DI
08809892362072
Basic UDI-DI
88000406CLASSIBS25V
FDA Product Code
NDP
EMDN Code
L159099 Odontostomatology instruments, reusable - other
GMDN Term
Surgical drill guide, reusable
Device Class
Class I
Regulation Number
872.3980
EU market of registration
Czechia
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (18)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No