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

ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL (FAS) (4) STENT, URETERAL (FAD) (2) endoscopic cytology brush (FDX) (2) CYSTOURETHROSCOPE (FBO) (1) Lithotriptor, electro-hydraulic (FFK) (1)

Premarket Exempt

No Yes

Clear

USA Elite System™ Standard Resectoscope Berry Rotating Sheath 24 Fr, - 00821925001329 Catalog Number :

Device Description : EBRS-24 Berry Sheath 24FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

USA Elite System™ Standard Resectoscope Berry Rotating Sheath 26 Fr, - 00821925001336 Catalog Number :

Device Description : EBRS-26 Berry Sheath 26Fr

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

USA Elite System™ Standard Resectoscope Berry Rotating Sheath 28 Fr, - 00821925001343 Catalog Number :

Device Description : EBRS-28 Berry Sheath 28FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

MULTI-FLEX 6.0 X 28 CM - 00821925001350 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

USA Elite System™ Baumrucker™ Working Element - 00821925001367 Catalog Number :

Device Description : EBWE MONO Baumrucker Working Element

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite™ Bipolar Baumrucker™ Working Element Gyrus® PK™ Super Pulse Sys - 00821925001374 Catalog Number :

Device Description : EBWE-BRPK Baumrucker Bipolar PK Working

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FBO

Prescription Use : Yes

Device Count : 1

MULTI-FLEX 8.5 X 22 CM - 00821925001404 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

CYBERWAND POWER CORD - 00821925001428 Catalog Number :

Device Description : CW-USLPC CYBERWAND POWER CORD

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FFK

Prescription Use : Yes

Device Count : 1

Cytology Brush 2.2 FR (0.733 mm), 115 cm - 00821925001435 Catalog Number :

Device Description : CYB-2 CYTOLOGY BRUSH 2.2FR-115CM

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FDX

Prescription Use : Yes

Device Count : 1

Cytology Brush 3.0 FR (1.0 mm), 115 cm - 00821925001442 Catalog Number :

Device Description : CYB-3 CYTOLOGY BRUSH 115 CM

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FDX

Prescription Use : Yes

Device Count : 1

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