Duns Number:796452311
Device Description: LW DISP,MULTILINK,5LEAD,PINCH,40",AHA
Catalog Number
6736
Brand Name
LW DISP,MULTILINK,5LEAD,PINCH,40",AHA
Version/Model Number
DLP-05BD-40AM-0100
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
MR Unsafe
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
-
Product Code
DSA
Product Code Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Public Device Record Key
d22ab50d-e3fa-4f71-b700-70c5908069a0
Public Version Date
June 21, 2021
Public Version Number
2
DI Record Publish Date
December 11, 2020
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 |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |