Duns Number:192135242
Device Description: PMI Operative Cholangiogram Catheter; tubing is 76cm in length, 16ga with a
Catalog Number
-
Brand Name
PMI
Version/Model Number
PMIORCA
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"
Yes
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
GBZ
Product Code Name
Catheter, Cholangiography
Public Device Record Key
20332a70-e75d-41be-adaf-a7ee664bdef2
Public Version Date
October 10, 2022
Public Version Number
3
DI Record Publish Date
September 23, 2016
Package DI Number
10812608021069
Quantity per Package
10
Contains DI Package
00812608021062
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 | 23 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 112 |