Perineologic
GUDID B371P10024
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.
CORBIN CLINICAL RESOURCES, LLC
Nonimplantable needle guide, single-use| Primary Device ID | B371P10024 |
| NIH Device Record Key | 051b10ff-32ec-43f4-8b79-0f410de53800 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Perineologic |
| Version Model Number | 1 |
| Company DUNS | 015831831 |
| Company Name | CORBIN CLINICAL RESOURCES, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com | |
| Phone | (240) 727-7662 |
| blake@perineologic.com |
Operating and Storage Conditions
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
| Storage Environment Temperature | Between 15 Degrees Celsius and 30 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B371P1002 [Primary] |
| HIBCC | B371P10020 [Package] Contains: B371P1002 Package: Package [1 Units] In Commercial Distribution |
| HIBCC | B371P10022 [Package] Contains: B371P10020 Package: Box [5 Units] In Commercial Distribution |
| HIBCC | B371P10024 [Package] Contains: B371P10022 Package: Carton [1 Units] In Commercial Distribution |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160414
FDA Product Code
| ITX | Transducer, Ultrasonic, Diagnostic |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2019-10-07 |
| Device Publish Date | 2019-07-11 |
On-Brand Devices [Perineologic]
| B371P1001 | The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposa |
| B371P10024 | The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposa |
| B371P10010 | The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposa |
| B371P10022 | The Perineologic PrecisionPoint™ Transperineal Access System is a sterile, single use, disposa |
Trademark Results [Perineologic]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PERINEOLOGIC 86835125 5182625 Live/Registered |
Corbin Clinical Resources, LLC 2015-12-01 |
 PERINEOLOGIC 86683921 5167185 Live/Registered |
Corbin Clinical Resources, LLC 2015-07-06 |
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