Duns Number:136718553
Device Description: EpiLong Soft Tray 17G x 3.5" (90mm) needle with 1cm graduation, plastic stylet and win EpiLong Soft Tray 17G x 3.5" (90mm) needle with 1cm graduation, plastic stylet and wings, EpiLong Soft 19G x 35'' (90cm) catheter with closed tip and 6 lateral openings (CONTINUOUS EPIDURAL) [10/box]
Catalog Number
NA
Brand Name
NA
Version/Model Number
TAL151
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
040b3faa-5b8e-4ade-99cc-c3819cd370d7
Public Version Date
June 28, 2022
Public Version Number
1
DI Record Publish Date
June 20, 2022
Package DI Number
20858965006759
Quantity per Package
10
Contains DI Package
00858965006755
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
NA
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 41 |