Duns Number:149818952
Catalog Number
LT100
Brand Name
St.Jude Medical™
Version/Model Number
LT100
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"
-
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
KDC
Product Code Name
INSTRUMENT, SURGICAL, DISPOSABLE
Public Device Record Key
5c8ba0fe-15c2-4a64-ae7c-2e7d87db2481
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
November 13, 2015
Package DI Number
15415067004779
Quantity per Package
20
Contains DI Package
05415067004772
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 70 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 1429 |
| 3 | A medical device with high risk that requires premarket approval | 736 |