Magicore R 554M6513

GUDID 08800039300995

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

Dental implant system
Primary Device ID08800039300995
NIH Device Record Key32a60a3e-a57c-4290-a17b-4cef15eb6b01
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagicore R 554M6513
Version Model NumberMagicore R
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039300995 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-09-11
Device Publish Date2018-10-05

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

08800039314084 - Magicore2024-10-30
08800039314169 - Magicore2024-10-30
08800039314176 - Magicore2024-10-30
08800039314183 - Magicore2024-10-30
08800039314268 - Magicore2024-10-30
08800039314275 - Magicore2024-10-30
08800039314282 - Magicore2024-10-30
08800039314367 - Magicore2024-10-30

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