Duns Number:071595540
Device Description: PlumePen Pro Disposable Capture Port Tips 4 in (10.16 cm)
Catalog Number
PROTIP420
Brand Name
PLUMEPEN
Version/Model Number
PROTIP420
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
GEI
Product Code Name
Electrosurgical, cutting & coagulation & accessories
Public Device Record Key
bf211227-34ad-43e3-a74c-09c9bdeba67f
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 06, 2020
Package DI Number
40845854061313
Quantity per Package
20
Contains DI Package
20845854061319
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1412 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2261 |
| 3 | A medical device with high risk that requires premarket approval | 95 |