FDA.report

MEGAPULSE 15+

Primary DI
04055207054024
Brand
MEGAPULSE 15+
Company
Richard Wolf GmbH
Model
487501605
Catalog number
487501605
Device description
LASER FIBER Ø 600µM DISPOSABLE Core Diameter 600µm, PACK=5 PCS, sterile, for single use
Published
2017-06-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
GEXPowered laser surgical instrument

Product Code Classifications

CodeDeviceSpecialtyClass
GEXPowered Laser Surgical InstrumentGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04055207054024PrimaryGS10
04055207054031Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04055207054024040552070540244055207054024
04055207054031040552070540314055207054031

GMDN Terms

TermDefinition
Laser lithotripsy systemAn 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.

Device Sizes

TypeValueUnit
Outer Diameter600Micrometer

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Contacts

PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags

DUNS number
315304071
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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