AccessGUDID - DEVICE: PROFORMA (20653405051418)

GUDID

Device Identifier (DI) Information

Brand Name: PROFORMA
Version or Model: 050906
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 050906
Company Name: Conmed Corporation

Primary DI Number: 20653405051418
Issuing Agency: GS1
Commercial Distribution End Date: April 04, 2017
Device Count: 5
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: PROFORMA HF 4.5 Cannula, Straight 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
DSA	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)

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
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

Public Device Record Key: b67177cd-b360-470e-a993-c0c41eea46f2
Public Version Date: November 19, 2020
Public Version Number: 4
DI Record Publish Date: September 24, 2016