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

OBTURATOR, FOR ENDOSCOPE (FEC) (4) Stent, Ureteral (FAD) (2) ELECTRODE, ELECTROSURGICAL, ACTIVE, UROLOGICAL (FAS) (1) STENT, URETERAL (FAD) (1) Ureteroscope and accessories, flexible/rigid (FGB) (1) pneumoperitoneum needle (FHO) (1)

Premarket Exempt

No Yes

Clear

7.0FR (2.3mm) X 26 cm URO-GUIDE ™ URETERAL STENT - 00821925001459 Catalog Number :

Device Description : The ureteral stent is intended to provide drainage from the kidney to the bladde The ureteral stent is intended to provide drainage from the kidney to the bladder, serving as an internal indwelling catheter.

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

UROPASS EXCH 7.0x28 CM WO/GW - 00821925001466 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

8.5FR (2.81mm) X 24 cm LUBRI-FLEX™ OPEN TIP URETERAL STENT HYDROPHILIC COATED TE - 00821925001473 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

USA Elite System™ Continuous Flow Laser Cystourethroscope Standard Ob - 00821925001480 Catalog Number :

Device Description : CLO-23 Blind Obturator

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FEC

Prescription Use : Yes

Device Count : 1

USA Elite System™ Continuous Flow Laser Cystourethroscope Outer Sheat - 00821925001497 Catalog Number :

Device Description : CLS-23 CF Laser Cysto SYS STD BEAK 23FR

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FEC

Prescription Use : Yes

Device Count : 1

USA Elite System™ Continuous Flow Laser Cystourethroscope Outer Sheat - 00821925001503 Catalog Number :

Device Description : CLS-23SB Elite LASER OUTER SHORT BEAK 23

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FEC

Prescription Use : Yes

Device Count : 1

USA Elite System™ Continuous Flow Laser Cystourethroscope Visual Obtu - 00821925001510 Catalog Number :

Device Description : CLV-23 Visual Obturator

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FEC

Prescription Use : Yes

Device Count : 1

USA Series™ Long Autoclavable Foroblique Telescope 30°, 2.7mm Diamete - 00821925001527 Catalog Number :

Device Description : G27L-30WA SlimLine Long Tele 30Deg 2.7MM

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FHO

Prescription Use : Yes

Device Count : 1

Lubricant For Use With Gyrus ACMI Flexible/Rigid Instruments - 00821925001534 Catalog Number :

Device Description : G925 Lubricant

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAS

Prescription Use : Yes

Device Count : 1

High Transmission Autoclavable Fiberoptic Light Guide Snap On 4 mm, 7 - 00821925001541 Catalog Number :

Device Description : G93 HIGH TRANS LIGHT CARRIER

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FGB

Prescription Use : Yes

Device Count : 1

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