Duns Number:071595540
Device Description: PROFORMA Cannula, Standard Tip, Straight
Catalog Number
050300
Brand Name
PROFORMA
Version/Model Number
050300
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 06, 2022
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
K950700,K950700,K950700
Product Code
ODD
Product Code Name
Endoscopic retrograde cholangiopancreatography (ERCP) cannula
Public Device Record Key
fd3d9723-6119-4119-9d8f-2f147948ff66
Public Version Date
June 07, 2022
Public Version Number
5
DI Record Publish Date
September 24, 2016
Package DI Number
10653405051275
Quantity per Package
3
Contains DI Package
20653405051272
Package Discontinue Date
June 06, 2022
Package Status
Not 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 |