Duns Number:796452311
Device Description: DLW,5LD,PINCH,INTEL,CHEST LEAD,40",AHA
Catalog Number
24455
Brand Name
DLW,5LD,PINCH,INTEL,CHEST LEAD,40",AHA
Version/Model Number
DLA-05BV-40AS-0000
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
aabafdee-3d38-41d6-af78-3cbbfe465f97
Public Version Date
August 01, 2019
Public Version Number
1
DI Record Publish Date
July 24, 2019
Package DI Number
90840828173721
Quantity per Package
10
Contains DI Package
90840828165313
Package Discontinue Date
-
Package Status
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 | 478 |
2 | A medical device with a moderate to high risk that requires special controls. | 8062 |