AccessGUDID - DEVICE: GREENLIGHT (04055207018170)

GUDID

Device Identifier (DI) Information

Brand Name: GREENLIGHT
Version or Model: 8632225
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8632.225
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018170
Issuing Agency: GS1
Commercial Distribution End Date: April 20, 2023
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 inner sheath 8655.344, 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

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61474	General/multiple surgical laser system beam guide, reusable	A surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FBO	CYSTOURETHROSCOPE

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
Angle: 30 degree

Device Record Status

Public Device Record Key: 34c3647b-1e53-4b83-81e0-74616ab8da55
Public Version Date: November 21, 2024
Public Version Number: 9
DI Record Publish Date: September 23, 2016