Certa Catheter - Certa Catheter™ continuous peripheral nerve block - FERROSAN MEDICAL DEVICES SP Z O O

Duns Number:426737794

Device Description: Certa Catheter™ continuous peripheral nerve block catheter set is indicated for deliveryof Certa Catheter™ continuous peripheral nerve block catheter set is indicated for deliveryof medication for regional anesthesia and pain management in lower extremity blocks.It may be used by a qualified healthcare professional in a perioperative monitoredcare setting.Certa Catheter™ is intended for use in adult patients only. It should always be insertedand placed under ultrasound guidance by a healthcare professional.The Certa Catheter has not been evaluated for use in upper extremity blocks.

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More Product Details

Catalog Number

-

Brand Name

Certa Catheter

Version/Model Number

R120D1

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2019

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

BSO

Product Code Name

Catheter, Conduction, Anesthetic

Device Record Status

Public Device Record Key

7cbacb89-97bf-4691-91d8-69f95c41e119

Public Version Date

July 22, 2020

Public Version Number

7

DI Record Publish Date

February 21, 2018

Additional Identifiers

Package DI Number

05902194190466

Quantity per Package

60

Contains DI Package

05902194190442

Package Discontinue Date

October 31, 2019

Package Status

Not in Commercial Distribution

Package Type

Shipper box