122 TAPER KIT

GUDID 08800271260293

Osstem Implant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800271260293
NIH Device Record Key7add733f-1f8d-4853-ac43-064db2448ff9
Commercial Distribution StatusIn Commercial Distribution
Brand Name122 TAPER KIT
Version Model NumberHK122TPK
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
GS108800271260293 [Primary]

FDA Product Code

NYEFixture Mount Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

Moist Heat or Steam Sterilization


[08800271260293]

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 KIT]

08809917147356H122TPK
08809917158840HK122TPK
08809917168498H122TPK
08809917070029O122TPK
08800271260293HK122TPK

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