Duns Number:025460908
Device Description: LEADWIRE,DISP,3-LEAD,PINCH,PHIL TPIN
Catalog Number
MDSLWP304
Brand Name
Medline
Version/Model Number
MDSLWP304
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
K181726,K181726,K181726
Product Code
DSA
Product Code Name
CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
Public Device Record Key
28d5b497-6aba-4d0d-94e9-70908bb6e90b
Public Version Date
April 25, 2022
Public Version Number
1
DI Record Publish Date
April 15, 2022
Package DI Number
20888277697543
Quantity per Package
25
Contains DI Package
10888277697546
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
BAG
| 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 |