122 TAPER FULL KIT

GUDID 08800271260286

Osstem Implant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800271260286
NIH Device Record Key77aa39a0-bd11-4729-a3b9-a248dbc7ca35
Commercial Distribution StatusIn Commercial Distribution
Brand Name122 TAPER FULL KIT
Version Model NumberHK122TPFK
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
GS108800271260286 [Primary]

FDA Product Code

NYEFixture Mount Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


[08800271260286]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-15
Device Publish Date2025-09-05

On-Brand Devices [122 TAPER FULL KIT]

08809917147349H122TPFK
08800121766524O122TPFK
08809917158833HK122TPFK
08809917168481H122TPFK
08809917070012O122TPFK
08800271260286HK122TPFK

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