AccessGUDID - DEVICE: GREENLIGHT (04055207018170)

GUDID

Device Identifier (DI) Information

Brand Name: GREENLIGHT
Version or Model: 8632225
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8632.225
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018170
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: LASER WORKING ELEMENT PASSIVE 30° closed, round, distal sheath end slanted, compatible with innenr sheath 8655344, and telescopes Ø 4mm, bayonet-cap, 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

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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 endoscope working guide	An endoscopic device that is a component of a rigid endoscope assembly that is used to assist the entry of a rigid endotherapy electrode into an appropriate rigid endoscope. It can provide either an active or passive activation of the electrode's cutting path. This is a reusable device.

FDA Product Code

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Product Code	Product Code Name
FBO	CYSTOURETHROSCOPE

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K935163	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

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

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Angle: 30 degree

Device Record Status

Public Device Record Key: 34c3647b-1e53-4b83-81e0-74616ab8da55
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016