AccessGUDID - DEVICE: NA (04055207009550)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 827055
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8270.55
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207009550
Issuing Agency: GS1
Commercial Distribution End Date: April 13, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: ESOPHAGOSCOPE-TUBE ID 6.3MM OD 7.5mm, TL 300mm, with proximal light connection, reusable

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:	No
Prescription Use (Rx):	No
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?
36653	Rigid optical oesophagoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the oesophagus. It is inserted into the body through the mouth. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine abnormalities in the tissue structure and mucous lining of the oesophagus. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EOX	ESOPHAGOSCOPE (FLEXIBLE OR RIGID)

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: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Hydrogen Peroxide
Ethylene Oxide
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Lumen/Inner Diameter: 6.3 Millimeter

Device Record Status

Public Device Record Key: b7984f01-8d29-4193-bf7a-5df7d174a6d6
Public Version Date: November 17, 2023
Public Version Number: 4
DI Record Publish Date: September 26, 2016