Duns Number:799751953
Device Description: 25g TW x 4.5" Quincke Spinal Needle w/ Introducer
Catalog Number
130-2545
Brand Name
Epimed
Version/Model Number
130-2545
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
K022029,K022029
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
8fe0d8c2-1e80-4794-a725-a6efaaea4441
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 20, 2017
Package DI Number
10818788020885
Quantity per Package
10
Contains DI Package
00818788020888
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 |