Neo Advance Instruments

GUDID 08800071020967

OSTEONIC CO.,Ltd.

Surgical screwdriver, reusable
Primary Device ID08800071020967
NIH Device Record Key7f5f2d99-7a10-4c2a-b7b6-2564798d1bd8
Commercial Distribution StatusIn Commercial Distribution
Brand NameNeo Advance Instruments
Version Model NumberPIS-0430-DRIVER
Company DUNS688999370
Company NameOSTEONIC CO.,Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800071020967 [Primary]

FDA Product Code

HXXScrewdriver

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800071020967]

Moist Heat or Steam Sterilization


[08800071020967]

Moist Heat or Steam Sterilization


[08800071020967]

Moist Heat or Steam Sterilization


[08800071020967]

Moist Heat or Steam Sterilization


[08800071020967]

Moist Heat or Steam Sterilization


[08800071020967]

Moist Heat or Steam Sterilization


[08800071020967]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-29
Device Publish Date2021-07-21

On-Brand Devices [Neo Advance Instruments]

08809399748676Bio Interference screw driver-1
08800071020967PIS-0430-DRIVER

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