MS system (Provisional)

GUDID 08809892359317

Osstem Implant Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08809892359317
NIH Device Record Keyc3eeef31-2eb2-4058-b260-bde2f9511f99
Commercial Distribution StatusIn Commercial Distribution
Brand NameMS system (Provisional)
Version Model NumberMSTPC
Company DUNS689051793
Company NameOsstem Implant Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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

Customer Support Contacts

Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com
Phone+1(821)012-3412
Emailchicson@osstem.com

Device Identifiers

Device Issuing AgencyDevice ID
GS108809892359317 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, implant, dental, endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


[08809892359317]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-13
Device Publish Date2023-11-04

On-Brand Devices [MS system (Provisional)]

08800000908014MSTPC
08809892359317MSTPC

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.