Duns Number:243730939
Catalog Number
-
Brand Name
PINPOINT PAQ®
Version/Model Number
PP9031
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
-
Product Code Name
-
Public Device Record Key
614163ef-c445-4188-8ddf-eba7c919d64d
Public Version Date
June 17, 2022
Public Version Number
5
DI Record Publish Date
September 23, 2016
Package DI Number
20858701006173
Quantity per Package
6
Contains DI Package
10858701006176
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |
3 | A medical device with high risk that requires premarket approval | 1 |