Magicore S

GUDID 08800039334259

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

Dental implant system
Primary Device ID08800039334259
NIH Device Record Key6db74182-e45d-4dbc-9bbf-3e11d1e894b0
Commercial Distribution StatusIn Commercial Distribution
Brand NameMagicore S
Version Model Number451M4513S
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 Usetrue
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
GS108800039334259 [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 Date2024-10-02
Device Publish Date2024-09-24

On-Brand Devices [Magicore S]

08800039335904552M5507S
08800039335898551M5507S
08800039335829554M5013S
08800039335812553M5013S
08800039335805552M5013S
08800039335799551M5013S
08800039335720554M5011S
08800039335713553M5011S
08800039335706552M5011S
08800039335690551M5011S
08800039335621554M5009S
08800039335614553M5009S
08800039335607552M5009S
08800039335591551M5009S
08800039335522554M5007S
08800039335508552M5007S
08800039335492551M5007S
08800039334280454M4513S
08800039334273453M4513S
08800039334266452M4513S
08800039334259451M4513S
08800039334181454M4511S
08800039334174453M4511S
08800039334167452M4511S
08800039334150451M4511S
08800039334082454M4509S
08800039334075453M4509S
08800039334068452M4509S
08800039334051451M4509S
08800039333986454M4507S
08800039333979453M4507S
08800039333962452M4507S
08800039333955451M4507S
08800039333887454M4013S
08800039333870453M4013S
08800039333863452M4013S
08800039333856451M4013S
08800039333788454M4011S
08800039333771453M4011S
08800039333764452M4011S
08800039333757451M4011S
08800039333689454M4009S
08800039333672453M4009S
08800039333665452M4009S
08800039333658451M4009S
08800039336925554M6511S
08800039336895551M6511S
08800039336826554M6509S
08800039336628554M6013S
08800039336611553M6013S

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