Cylinder Screw

GUDID 08800090601604

InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

Dental implant system
Primary Device ID08800090601604
NIH Device Record Key192bc284-dc9c-442f-a550-1cc258b8a0c8
Commercial Distribution StatusIn Commercial Distribution
Brand NameCylinder Screw
Version Model NumberMTCS
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800090601604 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800090601604]

Moist Heat or Steam Sterilization


[08800090601604]

Moist Heat or Steam Sterilization


[08800090601604]

Moist Heat or Steam Sterilization


[08800090601604]

Moist Heat or Steam Sterilization


[08800090601604]

Moist Heat or Steam Sterilization


[08800090601604]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-18
Device Publish Date2022-05-10

Devices Manufactured by InnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)

08800177337532 - Magicore S2024-12-25
08800177337617 - Magicore S2024-12-25
08800177337624 - Magicore S2024-12-25
08800177337631 - Magicore S2024-12-25
08800177337648 - Magicore S2024-12-25
08800177337723 - Magicore S2024-12-25
08800177337730 - Magicore S2024-12-25
08800177337747 - Magicore S2024-12-25

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