Duns Number:006261481
Device Description: LEAD 6416-200 TEMP PAC LEAD 1PK US
Catalog Number
-
Brand Name
NA
Version/Model Number
6416-200
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,K042190
Product Code
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
c5c6026f-1e21-4f49-a9af-54539c07be48
Public Version Date
February 05, 2021
Public Version Number
5
DI Record Publish Date
October 27, 2015
Package DI Number
20643169372768
Quantity per Package
5
Contains DI Package
00643169372764
Package Discontinue Date
April 23, 2018
Package Status
Not in Commercial Distribution
Package Type
PK
| 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 |