Duns Number:006261481
Device Description: POUCH 5409 DISPOSABLE EN
Catalog Number
-
Brand Name
NA
Version/Model Number
5409
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
May 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
P820003,P820003
Product Code
LWP
Product Code Name
Implantable pulse generator, pacemaker (non-CRT)
Public Device Record Key
211c5c16-4507-4a23-8197-cb32e7ac05c3
Public Version Date
November 06, 2020
Public Version Number
5
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 |