Duns Number:025460908
Device Description: LEADWIRE, DISP, 3-LEAD, SNAP, PHIL TPIN
Catalog Number
MDSLWS304
Brand Name
Medline
Version/Model Number
MDSLWS304
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
-
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
9a48e7ce-b501-4ebc-91c6-95540a4d8702
Public Version Date
December 18, 2020
Public Version Number
1
DI Record Publish Date
December 10, 2020
Package DI Number
30888277698004
Quantity per Package
100
Contains DI Package
20888277698007
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
MASTER CARTON
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 38540 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 85094 |
| 3 | A medical device with high risk that requires premarket approval | 2 |
| U | Unclassified | 7 |