FDA.reportPublic FDA data

S-12 RIWOSpine

Primary DI
J021304700001
Brand
S-12 RIWOSpine
Company
W & H Dentalwerk Bürmoos GmbH
Model
30470000
Device description
Surgical Handpiece 1:2 for RIWOSpine
Published
2024-02-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DZIDrill, Bone, Powered
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
GEYMotor, Surgical Instrument, Ac-Powered
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZIDrill, Bone, PoweredDental2
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including HandpieceEar, Nose, Throat2
GEYMotor, Surgical Instrument, Ac-PoweredGeneral, Plastic Surgery1
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J021304700000Direct MarkingHIBCC0
J021304700001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Drilling power tool attachment, basicA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a drilling function when an appropriate drill bit is inserted. It may include integral design features, e.g., have an angled head, be cannulated, have an attached Jacobs chuck, or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
300238441
Device count
1
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
J021102075581WI-75 E/KM 20:1102075582019-09-10
J021305020241Piezomed Pro Accessory305020242025-07-08
J021100355321ZA-55 Scaler B.F. A-dec100355322016-09-19
J021301790001EA-53 electric motor (A-dec)301790002023-07-11
J021304950011Foot control S-NW3304950012026-06-23
J021304970001Foot control S-N3304970002026-06-23
J021305040001Implantmed Plus II (SI-2100)305040002026-06-23
J021305050001Implantmed Plus II (SI-2101)305050002026-06-23
J021305060001Implantmed Plus II (SI-2102)305060002026-06-23
J021305070001Piezomed Module Plus II (SP-210 M)305070002026-06-23
J021122275011EB-75 Endea 16:1122275012018-08-31
J021122279011EB-79 Endea 2:1122279012018-08-31
J021300010031TG-98 L Megagen300010032022-03-30
J021300040031TG-97 L Megagen300040032022-03-30
J021301040001AM-25 A BC Air Motor301040002023-07-11
J021301120001AM-25 BC Air Motor301120002023-07-11
J021302120011WG-57 LT302120012023-07-11
J021302180001WK-66 LT S302180002019-09-10
J021303100021Assistina Twin MB-302303100022022-11-29
J021303980021MB-301 Assistina ONE303980022022-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850078396297TruPWR Torque Limiting Attachment Sterile, Single Use 90 in-lbEca Medical InstrumentsHWE2026-10-20
00850078396365PFT Adapter, DS, Mariner,105 in-lb (228-TXRX-009)Eca Medical InstrumentsHWE2026-10-20
00850078396372PFT Adapter, DS, Virata, 85 in-lb (228-TXRX-008)Eca Medical InstrumentsHWE2026-10-20
00889024709164CANNULATED 1.5MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00889024709171CANNULATED 2.0MM HEX DRIVERZimmer, Inc.HWE2026-10-19
00810111227872PinTreace Medical Concepts, Inc.HWE2026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-10-15
00810111228541Drill TackTreace Medical Concepts, Inc.HWE2026-10-15
03609820875712ACTEONSATELECDZI2026-10-13
03609820875743ACTEONSATELECDZI2026-10-13
05051471028500De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2023-06-16
05051471001169De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471002623De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471009585De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471010697De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471011441De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471011519De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471022348De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471036239De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471037281De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471040649De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471041578De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471045057De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471061545De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471112711De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471120976De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-28
05051471028432De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-24
05051471029835De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-24
05051471029972De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-24
05051471030008De Soutter MedicalDE SOUTTER MEDICAL LIMITEDGEY2022-11-24