Taper KIT

GUDID 08800040608615

Osstem Implant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800040608615
NIH Device Record Key0cf0f1ba-95a1-4180-a1cc-e39c46584b05
Commercial Distribution StatusIn Commercial Distribution
Brand NameTaper KIT
Version Model NumberOTSK
Company DUNS689051793
Company NameOsstem Implant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800040608615 [Primary]

FDA Product Code

NYEFixture Mount Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


[08800040608615]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-15
Device Publish Date2023-08-07

On-Brand Devices [Taper KIT]

08809917147387HTAPEK
08800040608615OTSK
08809917158871HKTAPEK
08809917108586HTAPEK
08809917070074OTSK
08800271260316HKTAPEK

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