FDA.reportPublic FDA data

Primado2

Primary DI
04560264529250
Brand
Primado2
Company
NAKANISHI INC.
Model
FC-74
Published
2025-01-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HBCMOTOR, DRILL, ELECTRIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HBCMotor, Drill, ElectricNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132264000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132264000PRIMADO2 TOTAL SURGICAL SYSTEMNakanishi, Inc.2013-12-17HBC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264529250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264529250045602645292504560264529250

GMDN Terms#

Term, Definition table
TermDefinition
Foot-switch, electricalAn electrically-powered pedal used by an operator of a medical device to regulate the activation and/or intensity of a parent device (e.g., electrosurgical system generator, laser, ophthalmic examination unit, dental drill/saw system control unit) to which it is connected, typically via an electrical cable. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690710546
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04589551388899VA170LUXS10VA170LUXS102026-10-06
04560264508422VA-SG-SCVA-SG-SC2026-10-05
04560264501911VA750LUX-SCVA750LUX-SC2026-10-01
04560264501935VA750-SCVA750-SC2026-10-01
04560264501942VA-SCVA-SC2026-10-01
04560264501980Water Filter Set (2m)Water Filter Set (2m)2026-10-01
04560264503649VA560LUX-SCVA560LUX-SC2026-10-01
04560264519022VA970-SCVA970-SC2026-10-01
04560264519039VA970LUX-SCVA970LUX-SC2026-10-01
04560264522510VA570-SCVA570-SC2026-10-01
04560264522527VA570LUX-SCVA570LUX-SC2026-10-01
04560264535213Water Filter Set (4m)Water Filter Set (4m)2026-10-01
04589551386765FC-15FC-152023-06-05
04560264522336Torque CalibratorTorque Calibrator2020-11-20
04560264566453NLZNLZ CDE2020-07-07
04560264565845TI-MAX X CONTRA/HPX95L2020-06-12
04560264565869TI-MAX X CONTRA/HPX25L2020-06-12
04560264565876TI-MAX X CONTRA/HPX20L2020-06-12
04560264565883TI-MAX X CONTRA/HPX15L2020-06-12
04560264565906TI-MAX X CONTRA/HPX952020-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809260473430TRAUSSaeshin Precision Co., Ltd.HBC2026-05-20
08809260475489TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475496TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475502TRAUSSaeshin Precision Co., Ltd.HBC2026-04-01
08809260475427TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475434TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475441TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475465TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
08809260475472TRAUSSaeshin Precision Co., Ltd.HBC2026-03-31
07630055508096PM2-Nose MIS D150Bien-Air Surgery SAHBC2025-03-21
07630055512604PM2-Nose MIS P160Bien-Air Surgery SAHBC2025-03-21
17630055506266Bur PM2-MIS D150 steel Ø2.0 StBien-Air Surgery SAHBC2025-03-21
17630055506273Bur PM2-MIS D150 steel Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506280Bur PM2-MIS D150 diam Ø2.0 StBien-Air Surgery SAHBC2025-03-21
17630055506297Bur PM2-MIS D150 diam Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506303Bur PM2-MIS D150 Mstick Ø1.8 StBien-Air Surgery SAHBC2025-03-21
17630055506310Bur PM2-MIS D150 Mstick Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506327Bur PM2-MIS D150 diam C Ø3.0 StBien-Air Surgery SAHBC2025-03-21
17630055506358Bur PM2-MIS D150 steel Ø4.0 StBien-Air Surgery SAHBC2025-03-21
07630055506375HS-Handpiece,straight,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506382HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506399HS-Handpiece,angled,70mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506405HS-Handpiece,angled,95mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506412HS-Handpiece, angled,125mm,80kBien-Air Surgery SAHBC2023-02-22
07630055506429HS-Handpiece,angled,150mm,80kBien-Air Surgery SAHBC2023-02-22
07630055507792Cable for Perforator MotorBien-Air Surgery SAHBC2023-02-22
07630055507815High-Speed Micro-Motor without cableBien-Air Surgery SAHBC2023-02-22
07630055507822Cable for HS-Micro-Motor,smallBien-Air Surgery SAHBC2023-02-22
07630055507839High-Speed Micro-Motor without cableBien-Air Surgery SAHBC2023-02-22
07630055505804Cranio Guard 15mm rotatingBien-Air Surgery SAHBC2023-02-10