Magicore Narrow

GUDID 08800039363327

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

Dental implant system
Primary Device ID08800039363327
NIH Device Record Key44e2c6a6-1889-4517-abce-4d7be2284c1e
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagicore Narrow
Version Model Number402M3009
Company DUNS631169224
Company NameInnoBioSurg Co.,Ltd(IBS implant Co.,Ltd)
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800039363327 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-01-12
Device Publish Date2023-01-04

On-Brand Devices [Magicore Narrow]

08800039363358405M3009
08800039363341404M3009
08800039363334403M3009
08800039363327402M3009
08800039363310401M3009
08800039363303405M3007
08800039363297404M3007
08800039363280403M3007
08800039363273402M3007
08800039363266401M3007

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