Duns Number:006261481
Device Description: LEAD 6416-200S TEMP FIX LEAD SINGLE 10L
Catalog Number
-
Brand Name
NA
Version/Model Number
6416-200S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 23, 2018
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"
-
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
K042190
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
211e5e0f-2f34-4687-a216-4b7bce52b3d0
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
June 11, 2015
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 | 102 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20495 |
| 3 | A medical device with high risk that requires premarket approval | 3601 |