AccessGUDID - DEVICE: E-LINE (04055207020036)

GUDID

Device Identifier (DI) Information

Brand Name: E-LINE
Version or Model: 8702534
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8702.534
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207020036
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: URETERORENOSCOPE 5° 6/7.5FR WL 430MM semi-rigid, with lateral ocular lens, working channel 1x4 (2x2.2)Fr, atraumatic distal tip, TL 563mm, 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

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Rigid ureterorenoscope	An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device.

GMDN Preferred Term Name

GMDN Definition

Rigid ureterorenoscope

An endoscope with a rigid inserted portion intended for the visual examination and treatment of the ureter and the renal pelvis. It is inserted through the external urethral orifice during a urological procedure. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle. This device is commonly used for the crushing or removal of stones and evaluation of pyelitis or renal failure. This is a reusable device.

FDA Product Code

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 430 Millimeter
Angle: 5 degree

Device Record Status

Public Device Record Key: 5047347b-3069-48b7-8446-65d34f31ca23
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 23, 2016