Duns Number:025460908
Device Description: LEADWIRE, DISP, 3-LEAD, SNAP, NIHON KOH
Catalog Number
MDSLWS306
Brand Name
Medline
Version/Model Number
MDSLWS306
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"
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
a0fbd9bc-3690-463c-a2fd-33aeb63a8578
Public Version Date
December 17, 2020
Public Version Number
1
DI Record Publish Date
December 09, 2020
Package DI Number
30888277698028
Quantity per Package
100
Contains DI Package
20888277698021
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 |