🚩 DEVICE: PROFORMA (20653405051418)

Device Identifier (DI) Information

PROFORMA
050906
Not in Commercial Distribution
050906
Conmed Corporation
20653405051418
GS1
April 04, 2017
5
071595540 *Terms of Use
PROFORMA HF 4.5 Cannula, Straight Taper Tip
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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
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FDA Product Code

[?]
Product Code Product Code Name
DSA CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K950700 000
No CLOSE

Sterilization

Yes
Yes
Sterilization Method [?]
Ethylene Oxide
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 4 and 49 Degrees Celsius
Storage Environment Temperature: between 40 and 120 Degrees Fahrenheit
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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
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Device Record Status

b67177cd-b360-470e-a993-c0c41eea46f2
November 19, 2020
4
September 24, 2016
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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
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: 00653405051414 CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+1(800)237-0169
CUSTOMER_SERVICE@CONMED.COM
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