FDA.reportPublic FDA data

Primado2

Primary DI
04560264561519
Brand
Primado2
Company
NAKANISHI INC.
Model
P200-3MC
Published
2016-09-16
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
04589551352364Direct MarkingGS10
04560264561519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04589551352364045895513523644589551352364
04560264561519045602645615194560264561519

GMDN Terms#

Term, Definition table
TermDefinition
Multi-purpose surgical power tool system, line-poweredAn assembly of devices designed to resect bones, tough tissues (e.g., cartilage, ligaments), and soft tissues during a surgical procedure; it is not dedicated to a specific clinical application. It includes a mains electricity (AC-powered) control unit which supplies low-voltage electricity, motors/handpieces/power tool attachments, and a variety of tools (e.g., drill bits, saw blades, burs, milling cutters, shavers, screwdriver bits, guide wires).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690710546
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
04589551366217P300-2A100P300-2A1002026-06-26
04589551366262P300-2A120P300-2A1202026-06-26
04589551366316P300-2S100P300-2S1002026-06-26
04589551366361P300-2S120P300-2S1202026-06-26
04589551366422PD-IN-2-120PD-IN-2-1202026-06-26
04560264548459Powder Handpiece(For Prophy use)Powder Handpiece(For Prophy use)2026-06-11
04560264548473Powder Handpiece(For Perio use)Powder Handpiece(For Perio use)2026-06-11
04560264579538CLM Bottole SetCLM Bottle Set2026-06-11
04560264579569CLM HolderCLM Holder2026-06-11
04589551391202Prophy Kit2Prophy Kit22026-06-11
04589551391219Perio Kit2Perio Kit22026-06-11
04589551395095Varios Combi Pro2 Basic SetVarios Combi Pro2 Basic Set2026-06-11
04589551395323CLM Module SetCLM Module Set2026-06-11
04589551395347Water Bottle KitWater Bottle Kit2026-06-11
04589551395439FC-83FC-832026-06-11
04589551386758VA-SG-TIP HOLDERVA-SG-TIP HOLDER2026-04-08
04589551395088Multi Pad2Multi Pad22026-06-02
04589551366583Sterile Cutting ToolUBS-RD70C2-082026-05-22
04589551366590Sterile Cutting ToolUBS-RD70C2-072026-05-22
04589551366606Sterile Cutting ToolUBS-RD50C2-082026-05-22

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
17630055506365Bur PM2-MIS D150 diam Ø4.0 StBien-Air Surgery SAHBC2025-03-21
17630055506525High-Speed Micro-Motor, smallBien-Air Surgery SAHBC2023-03-17
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