PRECIVIA® Version P - A rigid, non-powered device designed to lead a - FCI S A S FCI 20 22

Duns Number:763408366

Device Description: A rigid, non-powered device designed to lead a needle (not included) into its proper cours A rigid, non-powered device designed to lead a needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for many different procedures such as guides for urethral injections, guides for transrectal prostate biopsy, image-guided (e.g., ultrasound, MRI) for percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. Disposable imaging-supportive devices (e.g., ultrasound transducer cover/gel) may be included with the device. This is a single-use device.

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


More Product Details

Catalog Number

-

Brand Name

PRECIVIA® Version P

Version/Model Number

S5.200.P

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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

-

Product Code Details

Product Code

HNC

Product Code Name

Specula, Ophthalmic

Device Record Status

Public Device Record Key

f910fda0-9191-4e0c-98a8-250bfa90e5f6

Public Version Date

June 17, 2022

Public Version Number

2

DI Record Publish Date

May 25, 2021

Additional Identifiers

Package DI Number

23700773723915

Quantity per Package

25

Contains DI Package

13700773723918

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"FCI S A S FCI 20 22" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 82
2 A medical device with a moderate to high risk that requires special controls. 291
U Unclassified 60