AccessGUDID - DEVICE: PROFORMA (20653405051265)

GUDID

Device Identifier (DI) Information

Brand Name: PROFORMA
Version or Model: 050370
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 050370
Company Name: Conmed Corporation

Primary DI Number: 20653405051265
Issuing Agency: GS1
Commercial Distribution End Date: June 06, 2022
Device Count: 3
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: PROFORMA Cannula, Metal Ball, Pre-Curved

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
ODD	Endoscopic retrograde cholangiopancreatography (ERCP) cannula

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K950700	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1.7 Millimeter Catheter Gauge Diameter
Outer Diameter: 0.035 Inch
Outer Diameter: 0.89 Millimeter
Length: 200 Centimeter
Catheter Gauge: 5 French

Device Record Status

Public Device Record Key: 03dde79a-fd48-4945-94c1-87b84804d9d3
Public Version Date: June 07, 2022
Public Version Number: 5
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
10653405051268	3	20653405051265	2022-06-06	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: 00653405051261 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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