Osstell AB

Osstell AB

Address:Stampgaten 14,GOTEBORG Vastra Gotaland,SE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Handpiece, Direct Drive, Ac-Powered (EKX) (10)

Premarket Exempt

No

Clear

Osstell Beacon Instrument - 09010522000885 Catalog Number : 100668

Device Description : ISQ Measurement Instrument

Device Class :

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

MEGA ISQ II Instrument - 09010522001097 Catalog Number : 100722

Device Description : ISQ Measurement Instrument

Device Class : 1

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Mount - 09010522001158 Catalog Number : 100345

Device Description : SmartPeg Mount

Device Class :

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 01 - 09010522001165 Catalog Number : 100353

Device Description : ISQ Measurement Peg

Device Class :

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 02 - 09010522001172 Catalog Number : 100355

Device Description : ISQ Measurement Peg

Device Class :

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 03 - 09010522001189 Catalog Number : 100357

Device Description : ISQ Measurement Peg

Device Class : 1

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 04 - 09010522001196 Catalog Number : 100350

Device Description : ISQ Measurement Peg

Device Class : 1

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 05 - 09010522001202 Catalog Number : 100376

Device Description : ISQ Measurement Peg

Device Class : 1

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 06 - 09010522001219 Catalog Number : 100378

Device Description : ISQ Measurement Peg

Device Class : 1

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

Osstell SmartPeg Type 07 - 09010522001226 Catalog Number : 100380

Device Description : ISQ Measurement Peg

Device Class : 1

Duns Number: 633171269

Premarket Exempt : No

Product Code : EKX

Prescription Use : Yes

Device Count : 1

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