Duns Number:799751953
Device Description: 20g TW x 8.0" Coudé® Blunt Nerve Block Needle w/ Introducer
Catalog Number
119-2080
Brand Name
Epimed
Version/Model Number
119-2080
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"
-
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
K041843,K041843
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
1fdf1a6f-cf70-4716-b7df-a2a466bf8909
Public Version Date
June 25, 2021
Public Version Number
1
DI Record Publish Date
June 17, 2021
Package DI Number
10818788023626
Quantity per Package
10
Contains DI Package
00818788023629
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Case
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 293 |