Duns Number:040960379
Catalog Number
401766
Brand Name
Pacel™
Version/Model Number
401766
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
LDF
Product Code Name
ELECTRODE, PACEMAKER, TEMPORARY
Public Device Record Key
9753c88f-f179-4f05-b4bb-28ef0bb50bb7
Public Version Date
September 21, 2020
Public Version Number
4
DI Record Publish Date
July 31, 2015
Package DI Number
15414734001059
Quantity per Package
5
Contains DI Package
05414734001052
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 185 |
3 | A medical device with high risk that requires premarket approval | 30 |