Duns Number:317654283
Device Description: EpiLong NRFit Cath 20G x 90cm with closed tip radiopaque EpiLong NRFit Cath 20G x 90cm with closed tip radiopaque line, without steel stylet
Catalog Number
021163-37C
Brand Name
EpiLong NRFit Cath
Version/Model Number
021163-37C
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
March 15, 2025
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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"
Yes
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
bc66936b-31ae-4465-85ab-f90073f2e759
Public Version Date
March 16, 2021
Public Version Number
4
DI Record Publish Date
June 12, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 35 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 979 |