Duns Number:799751953
Device Description: Plastic L.O.R./ 20g TW x 3.5" Tuohy
Catalog Number
196-3020
Brand Name
Epimed
Version/Model Number
196-3020
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
K030562,K030562
Product Code
BSP
Product Code Name
NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER)
Public Device Record Key
bb59111e-5569-4b1c-9a87-45c1777d020f
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 24, 2017
Package DI Number
10818788021677
Quantity per Package
10
Contains DI Package
00818788021670
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 |