Duns Number:663190222
Device Description: AN-E EPIDURAL NEEDLE
Catalog Number
-
Brand Name
LCCS
Version/Model Number
ET18113-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
53c3db3a-ad4c-4736-9544-7d6261ec9dcc
Public Version Date
August 02, 2021
Public Version Number
1
DI Record Publish Date
July 24, 2021
Package DI Number
14895233608221
Quantity per Package
25
Contains DI Package
04895233608224
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 46 |