DISTRIBUDENT, LLC

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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

Powder, Porcelain (EIH) (10)

Premarket Exempt

Clear

ZIRento - D862Z16B21598ST0 Catalog Number :

Device Description : ZIRento 16 B2 15mm 98mm Step

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B21598STSI0 Catalog Number :

Device Description : ZIRento 16 B2 15mm 98mm Step - SI

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B22098ST0 Catalog Number :

Device Description : ZIRento 16 B2 20mm 98mm Step

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B22098STSI0 Catalog Number :

Device Description : ZIRento 16 B2 20mm 98mm Step - SI

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : No

Device Count : 1

ZIRento - D862Z16B22598ST0 Catalog Number :

Device Description : ZIRento 16 B2 25mm 98mm Step

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B22598STSI0 Catalog Number :

Device Description : ZIRento 16 B2 25mm 98mm Step - SI

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B31298ST0 Catalog Number :

Device Description : ZIRento 16 B3 12mm 98mm Step

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B31298STSI0 Catalog Number :

Device Description : ZIRento 16 B3 12mm 98mm Step - SI

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B31598ST0 Catalog Number :

Device Description : ZIRento 16 B3 15mm 98mm Step

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

ZIRento - D862Z16B31598STSI0 Catalog Number :

Device Description : ZIRento 16 B3 15mm 98mm Step - SI

Device Class : 2

Duns Number: 080458846

Premarket Exempt : No

Product Code : EIH

Prescription Use : Yes

Device Count : 1

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