Closing Screw

GUDID 08800039315364

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

Dental implant system
Primary Device ID08800039315364
NIH Device Record Key9d07ae35-cf8e-4bbd-9072-6fda04ea97a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameClosing Screw
Version Model NumberHISCY
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 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
GS108800039315364 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-23
Device Publish Date2024-10-15

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

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