Duns Number:002418234
Device Description: Sterile EpiGlide Tuohy Epidural Needle 17G x 3.5" with Fixed Wings
Catalog Number
578
Brand Name
Busse Hospital Disposables
Version/Model Number
578
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
K131006,K131006,K131006
Product Code
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
1c5a66cb-1846-4fd8-aa05-de57bf919f4f
Public Version Date
October 07, 2021
Public Version Number
1
DI Record Publish Date
September 29, 2021
Package DI Number
10849233005676
Quantity per Package
25
Contains DI Package
00849233005679
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 31 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 298 |