Duns Number:831737957
Device Description: 20 GA X 2" Huber Needle Used Only for Push and Pull of Saline Through Access Port of Lap B 20 GA X 2" Huber Needle Used Only for Push and Pull of Saline Through Access Port of Lap Band
Catalog Number
LBN-2020
Brand Name
MPM Medical Supply (Private Label)
Version/Model Number
LBN-2020
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
March 02, 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"
-
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
K883744,K883744,K883744
Product Code
FPA
Product Code Name
Set, Administration, Intravascular
Public Device Record Key
3e8defd7-38c4-432c-b002-ef4ec5cf37a9
Public Version Date
July 19, 2021
Public Version Number
5
DI Record Publish Date
January 05, 2017
Package DI Number
20859013006073
Quantity per Package
10
Contains DI Package
10859013006076
Package Discontinue Date
March 02, 2019
Package Status
Not in Commercial Distribution
Package Type
Unit Boxes
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 14 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |