AccessGUDID - DEVICE: NA (04055207020616)

GUDID

Device Identifier (DI) Information

Brand Name: NA
Version or Model: 8783412
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8783.412
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207020616
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: VIDEO-MEDIASTINOSCOPE WL 158MM outer dimension prox. Dilating 29x21mm, inner dimension dist. Ø 16mm, TL 214mm, integrated telescope, external suction tube, 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?
35187	Rigid optical mediastinoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the mediastinum (the intrapleural space located behind the sternum). It is inserted into the body through an artificial orifice created by an incision made during mediastinoscopy. Anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used to examine structures such as lymph nodes during a staging evaluation of lung cancer, or to establish the diagnosis of a tumour that is localized to the mediastinum. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EWY	MEDIASTINOSCOPE, SURGICAL

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: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 158 Millimeter

Device Record Status

Public Device Record Key: e8ad93f8-18ee-4165-b9c6-8191ee85d02b
Public Version Date: November 17, 2023
Public Version Number: 6
DI Record Publish Date: September 23, 2016