AccessGUDID - DEVICE: ELIMINATOR (20653405052576)

GUDID

Device Identifier (DI) Information

Brand Name: ELIMINATOR
Version or Model: 000849
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 000849
Company Name: Conmed Corporation

Primary DI Number: 20653405052576
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: CONMED Eliminator® 3-stage Pyloric/Colonic PET Balloon Dilator, 18 mm X 4 cm, 54F

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?
45712	Gastrointestinal/biliary dilation balloon catheter, non-medicated	A long, thin, flexible tube with an inflatable balloon at its distal tip intended to be used for gastrointestinal and/or biliary intraluminal dilation; it is typically used to endoscopically dilate strictures of the oesophagus, pylorus, colon and/or biliary tract. The balloon is inflated to its prescribed diameter to widen the affected passage of the tract. The device may consist of one or more lumen, may be of the fixed-wire or wire-guided type, and is not coated with a drug/pharmaceutical. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KNQ	Dilator, esophageal

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K940965	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 2.8 Millimeter
Device Size Text, specify: 18 Millimeter Balloon Outer Diameter
Device Size Text, specify: 4 Centimeter Balloon Length
Device Size Text, specify: 50 Pound per Square Inch Maximum Inflation Pressure
Device Size Text, specify: 3.4 Bar Maximum Inflation Pressure
Device Size Text, specify: 54 French Catheter Outer Diameter

Device Record Status

Public Device Record Key: 90616b25-2c43-4868-885e-958c522bfaa5
Public Version Date: December 23, 2024
Public Version Number: 6
DI Record Publish Date: September 24, 2016