Duns Number:071595540
Device Description: PROFORMA HF 4.5 Cannula, Straight Taper Tip
Catalog Number
050906
Brand Name
PROFORMA
Version/Model Number
050906
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
K050777,K050777,K050777
Product Code
FGE
Product Code Name
CATHETER, BILIARY, DIAGNOSTIC
Public Device Record Key
33c4af8a-e937-4e40-9ec0-5499e63e2a02
Public Version Date
November 19, 2020
Public Version Number
4
DI Record Publish Date
June 06, 2017
Package DI Number
50653405051419
Quantity per Package
5
Contains DI Package
40653405051412
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 |