Bone Compaction KIT

GUDID 08800271240516

Osstem Implant Co., Ltd.

Dental/maxillofacial surgical procedure kit, non-medicated, reusable
Primary Device ID08800271240516
NIH Device Record Key0df3926a-b68e-4365-881b-7c59a14c75ea
Commercial Distribution StatusIn Commercial Distribution
Brand NameBone Compaction KIT
Version Model NumberOBCK
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
GS108800271240516 [Primary]

FDA Product Code

NYEFixture Mount Kit

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


[08800271240516]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-11
Device Publish Date2025-02-03

On-Brand Devices [Bone Compaction KIT]

08809917166678HBCK
08809917165374OBCK
08800271219994OBCK
08800271219987HBCK
08800271241544HBCK
08800271240516OBCK

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.