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.
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
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
BSO
Product Code Name
Catheter, Conduction, Anesthetic
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
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