AccessGUDID - DEVICE: ProForma® (20653405051425)

GUDID

Device Identifier (DI) Information

Brand Name: ProForma®
Version or Model: 050907
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 050907
Company Name: Conmed Corporation

Primary DI Number: 20653405051425
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: ProForma® ERCP Precurved Cannula 4.50F, 190 cm, Curved Taper Tip

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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
FGE	CATHETER, BILIARY, DIAGNOSTIC

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K050777	000
K933649	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 40 and 120 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 49 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.7 Millimeter Catheter Gauge Diameter 1
Length: 190 Centimeter
Catheter Gauge: 4.5 French
Device Size Text, specify: 7 - 5 French Catheter Gauge Diameter 1
Outer Diameter: 0.89 Millimeter
Outer Diameter: 0.035 Inch
Device Size Text, specify: 1.5 Millimeter Catheter Gauge Diameter

Device Record Status

Public Device Record Key: fb154f9f-917b-427a-96ca-1da46fd724df
Public Version Date: August 01, 2024
Public Version Number: 6
DI Record Publish Date: 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
10653405051428	5	20653405051425		In Commercial Distribution	BOX

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: 00653405051421 CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)237-0169
Email: CUSTOMER_SERVICE@CONMED.COM

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