Duns Number:136718553
Device Description: CONTINUOUS EPIDURAL TRAYTuohy NRFit™ Epidural Needle 17G x 4“ withEpiLong Soft Catheter, C CONTINUOUS EPIDURAL TRAYTuohy NRFit™ Epidural Needle 17G x 4“ withEpiLong Soft Catheter, Closed Tip, 19G
Catalog Number
NA
Brand Name
NA
Version/Model Number
TAN101
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
OGE
Product Code Name
Epidural Anesthesia Kit
Public Device Record Key
f314714a-746a-401c-a5cc-f8f95e3267ae
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
June 12, 2019
Package DI Number
20858965006025
Quantity per Package
10
Contains DI Package
00858965006021
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |