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) (10)

Premarket Exempt

Yes

Clear

Zyris, Isolite Mouthpiece - 00810032660000 Catalog Number : CIL0101

Device Description : Mouthpiece, 10-Pack, Original Pediatric

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660017 Catalog Number : CIL0102

Device Description : Mouthpiece, Bulk (144), Original Pediatric

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 144

Zyris, Isolite Mouthpiece - 00810032660024 Catalog Number : CIL0103

Device Description : Mouthpiece, Bulk (100), Original Pediatric

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 100

Zyris, Isolite Mouthpiece - 00810032660031 Catalog Number : CIL0201

Device Description : Mouthpiece, 10-Pack, Original Small

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660048 Catalog Number : CIL0202

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

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 144

Zyris, Isolite Mouthpiece - 00810032660055 Catalog Number : CIL0301

Device Description : Mouthpiece, 10-Pack, Original Medium

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660062 Catalog Number : CIL0302

Device Description : Mouthpiece, Bulk (144), Original Medium

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 144

Zyris, Isolite Mouthpiece - 00810032660079 Catalog Number : CIL0401

Device Description : Mouthpiece, 10-Pack, Original Large

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660086 Catalog Number : CIL0501

Device Description : Mouthpiece, 10-Pack, Pediatric

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 10

Zyris, Isolite Mouthpiece - 00810032660093 Catalog Number : CIL0502

Device Description : Mouthpiece, Bulk (144), Pediatric

Device Class :

Duns Number: 068038277

Premarket Exempt : Yes

Product Code : EIF

Prescription Use : No

Device Count : 144

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