AccessGUDID - DEVICE: NA (10653405050872)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 000336
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 000336
Company Name: Conmed Corporation

Primary DI Number: 10653405050872
Issuing Agency: GS1
Commercial Distribution End Date: September 12, 2023
Device Count: 3
Labeler D-U-N-S® Number*: 071595540 *Terms of Use

Device Description: American Esophageal Dilator Cleaning Brush

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?
45686	Electrosurgical handpiece/electrode holder, single-use	A device intended to be used to house or fix an active electrosurgical handpiece/pen with its electrode when not being used by the surgeon during the surgical procedure. This is to secure the conducting unit, especially the electrode, within the sterile operating zone and protect it against potential adverse events. The holder will typically be fastened to an object within the sterile field (e.g., a drape, anaesthesia dividing arm, operating table). 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 [?]
Premarket Submission Number Not Available/Not Released

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
No Device Sizes

Device Record Status

Public Device Record Key: a704c62f-c33a-48ee-9f71-f0176c4ed61c
Public Version Date: September 13, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016