Duns Number:015831831
Device Description: The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, dis 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.
Catalog Number
-
Brand Name
Perineologic
Version/Model Number
1
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K160414,K160423,K160414,K160423,K160414,K160423,K160414,K160423
Product Code
FCG
Product Code Name
Biopsy Needle
Public Device Record Key
051b10ff-32ec-43f4-8b79-0f410de53800
Public Version Date
June 17, 2022
Public Version Number
4
DI Record Publish Date
July 11, 2019
Package DI Number
B371P10024
Quantity per Package
1
Contains DI Package
B371P10022
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 1 |