FDA.reportPublic FDA data

X1

Primary DI
04055207063811
Brand
X1
Company
Richard Wolf GmbH
Model
809510005
Catalog number
809510005
Device description
HIGH-SPEED-MOTOR MAX. 50000RPM for use with High-Speed-attachments, control by footswitch, reusable
Published
2024-07-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
GEYMOTOR, SURGICAL INSTRUMENT, AC-POWERED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04055207063811PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04055207063811040552070638114055207063811

GMDN Terms#

Term, Definition table
TermDefinition
Surgical power tool system control unit, line-poweredA mains electricity (AC-powered) component of a line-powered surgical/dental power tool system intended to step down the electrical power from the mains to supply the handpiece/motor (not included), and may also be intended to regulate some of the functions of the connected power tools (e.g., speed and torque); it may be intended for single or multiple clinical applications (i.e., dedicated or non-dedicated). This device may have integrated irrigation functionality and may be operated through hand and/or foot controls.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497043350info@richard-wolf.com

Regulatory Flags#

DUNS number
315304071
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04055207011478NA8863758863.752026-05-19
04055207011539NA8913608913.602026-05-19
04055207054390NA417022284170.22282026-05-19
04055207048788NA484076448407642026-05-13
04055207008881NA8061168061.162016-09-23
04055207008898NA8061258061.252016-09-23
04055207008904NA8061358061.352016-09-23
04055207008911NA8062358062.352016-09-23
04055207012611NA40702534070.2532016-09-23
04055207013823NA80611638061.1632016-09-23
04055207013830NA80612538061.2532016-09-23
04055207013854NA80613538061.3532016-09-23
04055207013861NA80613568061.3562016-09-23
04055207013878NA80614538061.4532016-09-23
04055207013885NA80614568061.4562016-09-23
04055207013892NA80614578061.4572016-09-23
04055207013908NA80618538061.8532016-09-23
04055207013922NA80622518062.2512016-09-23
04055207013939NA80623518062.3512016-09-23
04055207013946NA80624518062.4512016-09-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05051471221697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221703De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
05051471221710De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2026-05-27
10817417021323AsepticoASEPTICO, INC.GEY2026-04-08
10817417021330AsepticoASEPTICO, INC.GEY2026-04-08
10845854013144ERGOConmed CorporationGEY2026-03-24
00193982678265VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678326VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678975VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982678999VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679064VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679088VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679101VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679125VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679149VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679163VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679248VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679262VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679309VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679323VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
00193982679347VERZERAGLOBUS MEDICAL, INC.GEY2026-01-27
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHGEY2025-12-18
J021304950001Foot control S-NW3 (Dongle)W & H Dentalwerk Bürmoos GmbHGEY2025-12-18
J021304670001S-9 ES RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
J021304680001S-10 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
J021304700001S-12 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2024-02-07
10845854035009ADVANTAGEConmed CorporationGEY2023-12-04
J021303870021SpeedControl SC1 (M-UK1023)W & H Dentalwerk Bürmoos GmbHGEY2023-10-12
J021303880021SpeedControl SC1 (M-UK1015)W & H Dentalwerk Bürmoos GmbHGEY2023-10-12
J021303930011M-MH40 RIWOSpineW & H Dentalwerk Bürmoos GmbHGEY2023-10-12