Duns Number:831737957
Device Description: Guide Wire Introducer Needle With Window Wall Hub20GA X 1.5"
Catalog Number
GWI20015EWW
Brand Name
Manan Medical Products, Inc.
Version/Model Number
GWI20015EWW
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
K851834,K851834,K851834
Product Code
DWS
Product Code Name
Instruments, Surgical, Cardiovascular
Public Device Record Key
9fb29abb-be35-433b-b1d1-c18621bc2763
Public Version Date
July 19, 2021
Public Version Number
4
DI Record Publish Date
October 26, 2016
Package DI Number
20859013006189
Quantity per Package
10
Contains DI Package
10859013006182
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 |