Gyrus Acmi, Inc.

Address:2925 Appling Rd,BARTLETT,TN,38133,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) (7) STENT, URETERAL (FAD) (3)

Premarket Exempt

No Yes

Clear

UROPASS EXCH 8.5x28 CM WO/GW - 00821925001558 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

UROPASS II,6.0x28cm - 00821925001589 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

UROPASS II, 7.0 X 22 CM WO/GW - 00821925001596 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope Inner Sheath 27 - 00821925001602 Catalog Number :

Device Description : E2RIS-CF27 Elite 2 INNER ROT CF 27FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope Outer Sheath 25 - 00821925001619 Catalog Number :

Device Description : E2ROS-CF25 Elite 2 Outer ROT CF 25Fr

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope Outer Sheath 27 - 00821925001626 Catalog Number :

Device Description : E2ROS-CF27 E2 OUTER SHEATH CF ROT 27FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope System 25.6 Fr - 00821925001633 Catalog Number :

Device Description : E2RST-CF25 ELITE2 SHEATH SYS CF ROT 25FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope Timberlake Obtu - 00821925001657 Catalog Number :

Device Description : E2RTO-CF25 Elite 2 Rot CF Timber Obt 25F

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope Timberlake Obtu - 00821925001664 Catalog Number :

Device Description : E2RTO-CF27 Elite2 OBT TIMBER CF ROT 27FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

Elite 2 System™ Rotating Continuous Flow Resectoscope Visual Obturato - 00821925001671 Catalog Number :

Device Description : E2RVO-CF25 Elite 2 VISUALOBT CF ROT 25FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

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