Duns Number:192135242
Device Description: PMI Cholangiogram Combo Pack Includes: (PMIXL11) Disposable Operative Cholangiogram Cathe PMI Cholangiogram Combo Pack Includes: (PMIXL11) Disposable Operative Cholangiogram Catheter 11" and (PMIPIN15) Disposable Percutaneous Introducer 4" length and 14 gauge.
Catalog Number
PMIXLPIN
Brand Name
PMI
Version/Model Number
PMIXLPIN
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
Yes
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
ba5880f9-e9de-4c27-a08f-df39fe1c2de3
Public Version Date
October 10, 2022
Public Version Number
5
DI Record Publish Date
August 01, 2017
Package DI Number
00812608021550
Quantity per Package
10
Contains DI Package
00812608021543
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 |