Catalog Number
MCWED21160
Brand Name
Wedge
Version/Model Number
MCWED21160
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"
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
K172014
Product Code
DQY
Product Code Name
Catheter, percutaneous
Public Device Record Key
afc6bf00-f16d-4d4c-bfe9-8ed4db97b701
Public Version Date
October 10, 2022
Public Version Number
6
DI Record Publish Date
August 07, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 1709 |
3 | A medical device with high risk that requires premarket approval | 105 |