AccessGUDID - DEVICE: MEGAPULSE 15+ (04055207054000)

GUDID

Device Identifier (DI) Information

Brand Name: MEGAPULSE 15+
Version or Model: 487501365
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 487501365
Company Name: Richard Wolf GmbH

Primary DI Number: 04055207054000
Issuing Agency: GS1
Commercial Distribution End Date: October 17, 2017
Device Count: 5
Labeler D-U-N-S® Number*: 315304071 *Terms of Use

Device Description: LASER FIBER Ø 365µM DISPOSABLE Core Diameter 365µm, PACK=5 PCS, sterile, for single use

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:	Yes
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?
36037	Laser lithotripsy system	An assembly of devices consisting of a specialized ureteroscope, a laser resistant catheter, and a dedicated laser designed for the intracorporeal disintegration of ureteral stones (calculi). The assembly transmits the laser energy to the stone(s) which fragment. The debris may be removed forcefully or passed out later by natural means.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GEX	Powered laser surgical instrument

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Outer Diameter: 365 Micrometer

Device Record Status

Public Device Record Key: d8354548-ef40-4b58-94d6-0de95cd22edb
Public Version Date: May 29, 2023
Public Version Number: 6
DI Record Publish Date: June 28, 2017