STRADIS MEDICAL, LLC

Address:3600 Bur Wood Dr,WAUKEGAN,IL,60085,US

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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

Unit, Operative Dental (EIA) (5) Dental Hygiene Kit (NXZ) (3) General Purpose Dental Tray (OFX) (2)

Premarket Exempt

No Yes

Clear

STRADIS HEALTHCARE - M75220052BFH0 Catalog Number :

Device Description : CUSTOM DENTAL KIT PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : Yes

Product Code : NXZ

Prescription Use : Yes

Device Count : 1

STRADIS - M75220052BFH1 Catalog Number :

Device Description : CUSTOM DENTAL KIT PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

STRADIS HEALTHCARE - M75220053BFO0 Catalog Number :

Device Description : CUSTOM DENTAL KIT OPERATIVE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : Yes

Product Code : OFX

Prescription Use : Yes

Device Count : 1

STRADIS - M75220053BFO1 Catalog Number :

Device Description : CUSTOM DENTAL KIT OPERATIVE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

STRADIS - M75220059PED1 Catalog Number :

Device Description : CUSTOM DENTAL KIT PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

STRADIS - M75220059PEDR11 Catalog Number :

Device Description : CUSTOM DENTAL KIT PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

STRADIS HEALTHCARE - M75220060RHH0 Catalog Number :

Device Description : CUSTOM DENTAL KIT DENTAL PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : Yes

Product Code : NXZ

Prescription Use : Yes

Device Count : 1

STRADIS - M75220060RHH1 Catalog Number :

Device Description : CUSTOM DENTAL KIT DENTAL PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : No

Product Code : NXZ

Prescription Use : Yes

Device Count : 1

STRADIS HEALTHCARE - M75220061RHD0 Catalog Number :

Device Class : 1

Duns Number: 174262477

Premarket Exempt : Yes

Product Code : OFX

Prescription Use : Yes

Device Count : 1

STRADIS - M75220061RHD1 Catalog Number : 20061RHD

Device Description : CUSTOM CONVENIENCE KIT DENTAL PROCEDURE PACK

Device Class : 1

Duns Number: 174262477

Premarket Exempt : No

Product Code : EIA

Prescription Use : Yes

Device Count : 1

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