OsstellConnect

GUDID 09010522001073

Osstell AB

Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software Dental treatment application software
Primary Device ID09010522001073
NIH Device Record Key16acb37e-5f36-4ee3-a627-4fa8d9e69155
Commercial Distribution StatusIn Commercial Distribution
Brand NameOsstellConnect
Version Model NumberOsstell OsstellConnect
Company DUNS633171269
Company NameOsstell AB
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 Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109010522001073 [Primary]

FDA Product Code

OUGMedical Device Data System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-19
Device Publish Date2023-06-09

Devices Manufactured by Osstell AB

09010522002469 - Neoss SmartPeg Mount2023-12-14 SmartPeg Mount
09010522002087 - Osstell SmartPeg Type 992023-11-09
09010522002117 - Osstell SmartPeg Type 1002023-11-09 ISQ Measurement Peg
09010522002131 - Osstell SmartPeg Type 1012023-11-09 ISQ Measurement Peg
09010522002155 - Osstell SmartPeg Type 1022023-11-09 ISQ Measurement Peg
09010522002162 - Osstell SmartPeg Type 1032023-11-09 ISQ Measurement Peg
09010522002186 - Osstell SmartPeg Type 1042023-11-09 ISQ Measurement Peg
09010522002223 - Osstell SmartPeg Type 1062023-11-09 ISQ Measurement Peg

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