AccessGUDID - DEVICE: E-LINE (04055207020029)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 8702533
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8702.533
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207020029
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: URETERORENOSCOPE 5° 6/7.5FR WL 315MM semi-rigid, with lateral ocular lens, working channel 1x4 (2x2.2)Fr, atraumatic distal tip, TL 448mm, fiber image carrier

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?
37112	Rigid optical ureterorenoscope	An endoscope with a rigid or semi-rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis; some types may have a flexible tip at the distal end of the inserted portion. It is inserted through the external urethral orifice during a urological procedure whereby anatomical images are transmitted to the user through relayed lens optics or a fibreoptic bundle. This device is typically used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FGB	Ureteroscope and accessories, flexible/rigid

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
Hydrogen Peroxide
Ethylene Oxide

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 315 Millimeter
Angle: 5 degree

Device Record Status

Public Device Record Key: 242097c1-c8c5-4520-913b-af788fa983df
Public Version Date: November 17, 2023
Public Version Number: 5
DI Record Publish Date: September 23, 2016