AccessGUDID - DEVICE: GREENLIGHT (04055207018248)

GUDID

Device Identifier (DI) Information

Brand Name: GREENLIGHT
Version or Model: 8632912
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8632.912
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207018248
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: LASER WORKING INSERT 30 color code black, round, without pivot angle limitation, distal sheath end slanted, compatible with sheaths 8632027, 8655345, and telescopes Ø 4mm, 0°-30°, 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?
37085	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.	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: f0c19750-40a6-4339-8011-cf4f3e996360
Public Version Date: November 21, 2024
Public Version Number: 6
DI Record Publish Date: September 23, 2016