Duns Number:079506014
Device Description: 5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER ONLY
Catalog Number
JT110500850
Brand Name
5F X 8.5CM ALLEVIO SPG NERVE BLOCK CATHETER ONLY
Version/Model Number
JT110500850
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 22, 2019
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"
Yes
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
-
Product Code
KCJ
Product Code Name
Applicator, Ent
Public Device Record Key
7bb10a4a-91dd-43fa-86f5-1575a1cddecc
Public Version Date
May 03, 2019
Public Version Number
4
DI Record Publish Date
August 25, 2015
Package DI Number
50810988020793
Quantity per Package
5
Contains DI Package
00810988020798
Package Discontinue Date
April 22, 2019
Package Status
Not in Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 3 |
2 | A medical device with a moderate to high risk that requires special controls. | 63 |