🚩 DEVICE: PROFORMA (20653405051418)
Device Identifier (DI) Information
PROFORMA
050906
Not in Commercial Distribution
050906
Conmed Corporation
050906
Not in Commercial Distribution
050906
Conmed Corporation
PROFORMA HF 4.5 Cannula, Straight Taper Tip
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
16429 | ERCP catheter, non-balloon, non-electrical, single-use |
A non-electrical flexible tube inserted through a flexible endoscope, after its placement in the duodenum via the oral cavity, for the endoscopic cannulation of the gastrointestinal ductal system (i.e., the pancreatic, hepatic, and/or common bile ducts) during endoscopic retrograde cholangiopancreatography (ERCP). It is typically a single-lumen device made of radiopaque plastic materials with incremental markings at the distal tip, used to deliver a contrast medium to the ducts for their radiographic visualization; it does not incorporate a balloon. This is a single-use device.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
DSA | CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K950700 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 4 and 49 Degrees Celsius |
Storage Environment Temperature: between 40 and 120 Degrees Fahrenheit |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 1.5 Millimeter Catheter Gauge |
Device Size Text, specify: 1.7 Millimeter Catheter Gauge Diameter |
Device Size Text, specify: 0.89 Millimeter Wire Outer Diameter |
Length: 190 Centimeter |
Catheter Gauge: 4.5 French |
Device Size Text, specify: 0.035 Inch Wire Outer Diameter |
Device Size Text, specify: 7-5 French Catheter Gauge Catheter Diameter |
Device Record Status
b67177cd-b360-470e-a993-c0c41eea46f2
November 19, 2020
4
September 24, 2016
November 19, 2020
4
September 24, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
10653405051411 | 5 | 20653405051418 | 2017-04-04 | Not in Commercial Distribution | BOX |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00653405051414
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
CUSTOMER_SERVICE@CONMED.COM