Duns Number:006261481
Device Description: SFTWR 9790XLA LEAD PATIENT LONG 9790 TAC
Catalog Number
-
Brand Name
NA
Version/Model Number
9790XLA
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
January 25, 2019
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
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
P890003
Product Code
KRG
Product Code Name
Programmer, pacemaker
Public Device Record Key
8ad4368e-a2f0-488d-b3c6-fa6e0b4a2163
Public Version Date
February 18, 2019
Public Version Number
4
DI Record Publish Date
September 23, 2014
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 |