ZYRIS, INC.

Address:6868A Cortona Dr,Santa Barbara,CA,93117,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

ACCESSORIES, RETRACTOR, DENTAL (EIF) (6) LIGHT, OPERATING, DENTAL (EAZ) (2) UNIT, SUCTION OPERATORY (EBR) (2)

Premarket Exempt

Yes

Clear

Zyris, Isolite Mouthpiece - 00810032660208 Catalog Number : CIL0901

Device Description : Mouthpiece, 10-Pack, Large

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660215 Catalog Number : CIL0902

Device Description : Mouthpiece, Bulk (144), Large

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 144

Zyris, Isolite Mouthpiece - 00810032660222 Catalog Number : CIL0903

Device Description : Mouthpiece, Bulk (100), Large

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 100

Zyris, Isolite Mouthpiece - 00810032660239 Catalog Number : CIL1101

Device Description : Mouthpiece, 10-Pack, Extra Small

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660246 Catalog Number : CIL1102

Device Description : Mouthpiece, Bulk (144), Extra Small

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 144

Zyris, Isolite Mouthpiece - 00810032660253 Catalog Number : CIL1103

Device Description : Mouthpiece, Bulk (100), Extra Small

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 100

Zyris, Isodry - 00810032660260 Catalog Number : EID0101

Device Description : System, Isodry

Device Class : 1

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EBR

Prescription Use : No

Device Count : 1

Zyris, Isolite, i2 - 00810032660277 Catalog Number : EIL0201

Device Description : System, Isolite

Device Class : 1

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : No

Device Count : 1

Zyris, Isolite, i3 - 00810032660284 Catalog Number : EIL0301

Device Description : System, Isolite, i3

Device Class : 1

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EAZ

Prescription Use : No

Device Count : 1

Zyris, Isovac - 00810032660291 Catalog Number : EIV0101

Device Description : Isovac, Single

Device Class : 1

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EBR

Prescription Use : No

Device Count : 1

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