FDA.reportPublic FDA data

Primado

Primary DI
04560224991080
Brand
Primado
Company
NAKANISHI INC.
Model
PD-EZ-M
Published
2020-12-02
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
EFBHandpiece, air-powered, dental
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFBHandpiece, Air-Powered, DentalDental1
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163483000
K202120000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163483000PANA SPRAY PlusNakanishi, Inc.2017-08-15EFB
K202120000P300 AttachmentNakanishi, Inc.2021-10-22HBE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560224991080PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560224991080045602249910804560224991080

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument maintenance lubricantA non-sterile solution intended to be applied to a surgical instrument prior to sterilization for purposes of lubrication/maintenance (e.g., to prevent moving or mating parts from sticking together during use, inhibit corrosion, and to improve longevity of the instrument); it is not dedicated to a particular type of surgical instrument. It may be a water-soluble solution, commonly known as instrument milk because of its white colour when mixed with water, in which the instrument is immersed, or it may be a spray that is sprayed onto the instrument. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
690710546
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
04589551366613Sterile Cutting ToolUBS-RD50C2-072026-05-22
04560264564213iProphy mobileiProphy mobile Motor2020-06-18
04589551392940WrenchWrench2026-04-27
04589551389186VS4-LED-HPSCVS4-LED-HPSC2026-04-23
04589551389216FC-86FC-862026-04-23
04589551390960VarioSurg 4 (120V)VarioSurg 4 (120V)2026-04-23
04589551390977VarioSurg 4 w/o FC (120V)VarioSurg 4 w/o FC (120V)2026-04-23
04589551393398FC-78FC-782026-04-23
04589551389001CR-30CR-302026-04-20
04589551391462M-RE2M-RE22026-04-20
04589551391479M-ST1M-ST12026-04-20
04589551391486M-OC1RM-OC1R2026-04-20
04589551391493M-OC1LM-OC1L2026-04-20
04589551393589SG12SG122026-04-20
04560264510913Ti-Max XX57L2020-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842078125748CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130261CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)Eca Medical InstrumentsHWE2026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)Eca Medical InstrumentsHWE2026-06-05
10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
07613327648362PANGEAStryker GmbHHWE2026-06-02
00810021439778DCI EdgeDCI International, LLCEFB2026-06-01
00810021439785DCI EdgeDCI International, LLCEFB2026-06-01
07640397422028Statcare sprayDent4You AGEFB2026-04-24
07640397422035Statmatic sprayDent4You AGEFB2026-04-24
07613327652703N/ASTRYKER CORPORATIONHWE2026-04-15
07613327652710PROstepSTRYKER CORPORATIONHWE2026-04-13