DEVICE: MEGAPULSE 15+ (04055207054000)

Device Identifier (DI) Information

MEGAPULSE 15+
487501365
In Commercial Distribution
487501365
Richard Wolf GmbH
04055207054000
GS1

5
315304071 *Terms of Use
LASER FIBER Ø 365µM DISPOSABLE Core Diameter 365µm, PACK=5 PCS, sterile, for single use
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
Yes
No
No
No
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
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.
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
GEX Powered laser surgical instrument
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

Yes
No
Sterilization Method [?]
No Sterilization Methods Found
CLOSE

Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between 10 and 30 Degrees Celsius
CLOSE

Clinically Relevant Size

[?]
Size Type Text
Outer Diameter: 365 Micrometer
CLOSE

Device Record Status

d8354548-ef40-4b58-94d6-0de95cd22edb
March 29, 2018
2
June 28, 2017
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: 04055207054017 CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
+497043350
info@richard-wolf.com
CLOSE