OSTEOTOME N 1 OST 01

GUDID 07899995254498

OSTEOTOME N 1

Sin Sistema de Implante Nacional S/A

Dental osteotome
Primary Device ID07899995254498
NIH Device Record Key21174bd9-bbef-4d7d-ab38-842933bbe8ca
Commercial Distribution StatusIn Commercial Distribution
Brand NameOSTEOTOME N 1
Version Model NumberOST 01
Catalog NumberOST 01
Company DUNS904569092
Company NameSin Sistema de Implante Nacional S/A
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 Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899995254498 [Primary]

FDA Product Code

NDPAccessories, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


[07899995254498]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

Devices Manufactured by Sin Sistema de Implante Nacional S/A

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07899995243843 - DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.2025-12-31 DRIVER HANDP. HEX.1.4MM EXT. LONG ANG.
07899995243850 - DRIVER HANDPIECE HEX.1.4MM LONG ANG.2025-12-31 DRIVER HANDPIECE HEX.1.4MM LONG ANG.
07899995243874 - DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.2025-12-31 DRIVER HANDPIECE HEX.1.4MM MEDIUM ANG.
07899995243881 - DRIVER HANDPIECE HEX.1.4MM SHORT ANG.2025-12-31 DRIVER HANDPIECE HEX.1.4MM SHORT ANG.

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