CORBIN CLINICAL RESOURCES, LLC

Address:183 North Centre Street,Cumberland,MD,21502,US

Want to know more about this Organization? Request more information now!

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

Biopsy Needle (FCG) (2) Transducer, Ultrasonic, Diagnostic (ITX) (2)

Premarket Exempt

Clear

Perineologic - B371P1001 Catalog Number :

Device Description : The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, singl The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of a Carriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasound transducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle. The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as a means to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use of ultrasound-assisted guidance.

Device Class :

Duns Number: 015831831

Premarket Exempt : No

Product Code : ITX, FCG

Prescription Use : Yes

Device Count : 1

Perineologic - B371P1002 Catalog Number :

Device Description : The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, singl The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposable, needle guide consisting, of aCarriage and a Rail Clamp Assembly and Access Needle, that is intended for use with a cylindrical style trans-rectal ultrasoundtransducer (0.7” to .85” diameter BK #8658 or equivalent) associated with a BK ProFocus ultrasound system and a biopsy needle.The PrecisionPoint™ Transperineal Access System is designed to stabilize a Perineologic Access Needle on the anatomy as ameans to properly guide the anatomical placement of a biopsy needle into the prostate or other soft tissues through the use ofultrasound-assisted guidance.

Device Class : 2

Duns Number: 015831831

Premarket Exempt : No

Product Code : ITX, FCG

Prescription Use : Yes

Device Count : 1

Previous 1 Next