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

Stent, Ureteral (FAD) (4) FORCEPS, GENERAL & PLASTIC SURGERY (GEN) (3) DISLODGER, STONE, FLEXIBLE (FGO) (1) SURGICAL INSTRUMENTS, G-U, MANUAL (AND ACCESSORIES) (KOA) (1) endoscopic injection needle, gastroenterology-urology (FBK) (1)

Premarket Exempt

No Yes

Clear

7.0FR (2.3mm) X 26 cm LUBRI-FLEX™ OPEN TIP URETERAL STENT HYDROPHILIC COATED TE - 00821925001138 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

6.0FR (2.0mm) X 16 cm URO-GUIDE ™ URETERAL STENT - 00821925001152 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

6.0FR (2.0mm) X 20 cm URO-GUIDE ™ URETERAL STENT - 00821925001169 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

6.0FR (2.0mm) X 22 cm URO-GUIDE ™ URETERAL STENT - 00821925001206 Catalog Number :

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FAD

Prescription Use : Yes

Device Count : 1

USA Elite System Rigid Optical Cup Tearing Biopsy Forceps - 00821925001237 Catalog Number :

Device Class : 1

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

USA Elite System Rigid Optical Grasping Forceps - 00821925001244 Catalog Number :

Device Class : 1

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

USA Elite System Rigid Optical Cup Cutting Biopsy Forceps - 00821925001251 Catalog Number :

Device Class : 1

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : GEN

Prescription Use : Yes

Device Count : 1

USA Elite System™ Rigid Optical Stone Crushing Forceps - 00821925001268 Catalog Number :

Device Description : E8217 Elite Rigid Optical Stone Crushing

Device Class : 2

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : FGO

Prescription Use : Yes

Device Count : 1

USA Elite System Rigid Optical Hook Scissors - 00821925001275 Catalog Number :

Device Class : 1

Duns Number: 007198742

Premarket Exempt : Yes

Product Code : KOA

Prescription Use : Yes

Device Count : 1

USA Elite System™ Endoscopic Injection Needle - 00821925001299 Catalog Number :

Device Description : EAWE-N Reusable Injection Needle

Device Class : 2

Duns Number: 007198742

Premarket Exempt : No

Product Code : FBK

Prescription Use : Yes

Device Count : 1

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