AccessGUDID - DEVICE: CONMED CleanGuide (06971890564542)

GUDID

Device Identifier (DI) Information

Brand Name: CONMED CleanGuide
Version or Model: CG-06-1
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Jiangsu Grit Medical Technology Co., Ltd.

Primary DI Number: 06971890564542
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 554536935 *Terms of Use

Device Description: Disposable OTW Esophageal Dilators

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?
38821	Endoscopic-access dilator, single-use	A device intended to be used to dilate a body lumen or access channel to facilitate the introduction of endoscopic instruments percutaneously (through the skin) or through a natural orifice (e.g., urethra). It may be a flexible or rigid rod/tube with a tapered distal tip. 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: Yes 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 19e74865-b453-47cd-850f-3ddc4ae33369
Public Version Date: August 27, 2021
Public Version Number: 2
DI Record Publish Date: April 11, 2021