100698

GUDID 04055207069257

GEL PAD ASSORTMENT F10 G10 for use with the PiezoWave 2, penetration depth 10 mm, 20 mm, 30 mm, 40 mm, 50 mm and 60 mm

Richard Wolf GmbH

Electromechanical orthopaedic extracorporeal shock wave therapy system
Primary Device ID04055207069257
NIH Device Record Key769d2836-22e8-4de1-8a69-60d733d4ec62
Commercial Distribution StatusIn Commercial Distribution
Version Model Number100698
Catalog Number100698
Company DUNS315304071
Company NameRichard Wolf GmbH
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com
Phone+497043350
Emailinfo@richard-wolf.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
Storage Environment TemperatureBetween 5 Degrees Celsius and 40 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing AgencyDevice ID
GS104055207069257 [Primary]

FDA Product Code

ISAMassager, therapeutic, electric

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-03-20
Device Publish Date2026-03-12

Devices Manufactured by Richard Wolf GmbH

04055207069226 - NA2026-03-20 THERAPY SOURCE F10 G10 BLUE for USA only, for use with PiezoWave 2, point-focused, with trigger button, maximum penetration dep
04055207069257 - NA2026-03-20GEL PAD ASSORTMENT F10 G10 for use with the PiezoWave 2, penetration depth 10 mm, 20 mm, 30 mm, 40 mm, 50 mm and 60 mm
04055207069257 - NA2026-03-20 GEL PAD ASSORTMENT F10 G10 for use with the PiezoWave 2, penetration depth 10 mm, 20 mm, 30 mm, 40 mm, 50 mm and 60 mm
04055207068243 - VERTEBRIS2026-02-18 KNOT PUSHER Ø 2.5MM WL 330MM reusable
04055207069691 - NA2026-02-18 CAGE SLEEVE ID 15MM OD 16 mm, TL 145 mm, reusable
04055207069707 - NA2026-02-18 CAGE SLEEVE SQUARE ID 15MM OD 16 mm, TL 145 mm, reusable
04055207069714 - NA2026-02-18 CAGE SLEEVE SQUARE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
04055207069721 - NA2026-02-18 CAGE SLEEVE ID 13.6MM OD 14,6 mm, TL 145 mm, reusable
04055207069738 - NA2026-02-18 DILATOR SQUARE ID 9.5MM OD 14.9MM TL 210 mm, reusable

© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.