Duns Number:136718553
Device Description: EpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ (90mm) withSPROTTE® Spinal Needle 25G and Ep EpiSpin Lock Tuohy Epidural Needle 17G x 3.5“ (90mm) withSPROTTE® Spinal Needle 25G and EpiLong Soft Catheter, Closed Tip, 19Gwith Drug for Spinal Anesthesia
Catalog Number
-
Brand Name
N/A
Version/Model Number
TCLO201
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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"
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
9c650477-d99f-410a-a646-76dd7cb43274
Public Version Date
May 24, 2021
Public Version Number
1
DI Record Publish Date
May 14, 2021
Package DI Number
20858965006667
Quantity per Package
10
Contains DI Package
00858965006663
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 |