Duns Number:136718553
Device Description: COMBINED SPINAL EPIDURAL TRAYEpiSpin Tuohy NRFit™ Epidural Needle 17G x 3.5“ withSPROTTE® COMBINED SPINAL EPIDURAL TRAYEpiSpin Tuohy NRFit™ Epidural Needle 17G x 3.5“ withSPROTTE® NRFit Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19G0.75% Bupivacaine HCl with 8.25% Dextrose
Catalog Number
NA
Brand Name
NA
Version/Model Number
TCN101
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
OFT
Product Code Name
Spinal Epidural Anesthesia Kit
Public Device Record Key
21abed02-5b7e-466f-a1d9-6864292e44e5
Public Version Date
July 22, 2019
Public Version Number
2
DI Record Publish Date
June 12, 2019
Package DI Number
20858965006094
Quantity per Package
10
Contains DI Package
00858965006090
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 |