Duns Number:329515725
Device Description: Epidural needle 20G x 45 mm
Catalog Number
98045-20
Brand Name
Temena
Version/Model Number
98045-20
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
BSP
Product Code Name
Needle, Conduction, Anesthetic (W/Wo Introducer)
Public Device Record Key
a1f1219b-cc1b-48a4-90f2-23da05be40b9
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 28, 2017
Package DI Number
03700339702121
Quantity per Package
25
Contains DI Package
03700339712120
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. | 144 |