Duns Number:663190222
Device Description: AN-E EPIDURAL NEEDLE
Catalog Number
-
Brand Name
LCCS
Version/Model Number
ET20155-D-LC
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"
-
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
898bddb5-0d97-46bf-abaa-0cc1be7b9eeb
Public Version Date
January 09, 2020
Public Version Number
1
DI Record Publish Date
January 01, 2020
Package DI Number
64895233608639
Quantity per Package
40
Contains DI Package
14895233608634
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |