Gyrus Acmi, Inc.

Address:800 West Park Drive,Westborough,MA,01581,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

One-Way Air-Leak Valve (OAZ) (6) Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece (ERL) (3) Bronchoscope Accessory (KTI) (1)

Premarket Exempt

No Yes

Clear

Celeris - 00821925044906 Catalog Number :

Device Description : DISP SINUS DEBRIDER, 2MM STRT, BIP, TYPE A

Device Class :

Duns Number: 007198742

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Celeris - 00821925044944 Catalog Number :

Device Description : DISP SINUS DEBRIDER, REUSABLE PWR PACK

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 1

Celeris - 00821925045170 Catalog Number :

Device Description : DISP SINUS DEBRIDER, 4MM MALL, STD, SERRATED

Device Class :

Duns Number: 007198742

Premarket Exempt : No

Product Code : ERL

Prescription Use : Yes

Device Count : 5

Spiration Valve System - 00896506002088 Catalog Number :

Device Description : Valve in Cartridge , 5mm

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002095 Catalog Number :

Device Description : Valve in Cartridge, 6mm

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002101 Catalog Number :

Device Description : Valve in Cartridge, 7mm

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002118 Catalog Number :

Device Description : Deployment Catheter and Loader, 2.6

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002125 Catalog Number :

Device Description : Airway Sizing Kit

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

ViziShot FLEX - 00896506002132 Catalog Number :

Device Description : Single Use Aspiration Needle

Device Class : 2

Duns Number: 117521967

Premarket Exempt : Yes

Product Code : KTI

Prescription Use : No

Device Count : 1

Spiration Valve System - 00896506002187 Catalog Number :

Device Description : Deployment Catheter and Loader, 2.6

Device Class :

Duns Number: 117521967

Premarket Exempt : No

Product Code : OAZ

Prescription Use : No

Device Count : 1

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