FDA.reportPublic FDA data

Irrigation Pump Set

Primary DI
04560264521131
Brand
Irrigation Pump Set
Company
NAKANISHI INC.
Model
Irrigation Pump Set
Published
2017-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
EBWController, Foot, Handpiece And Cord

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBWController, Foot, Handpiece And CordDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04560264557413Direct MarkingGS10
04560264553156PackageGS11In Commercial Distribution
04560264553163PackageGS12In Commercial Distribution
04560264521131PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04560264557413045602645574134560264557413
04560264553156045602645531564560264553156
04560264553163045602645531634560264553163
04560264521131045602645211314560264521131

GMDN Terms#

Term, Definition table
TermDefinition
Suction/irrigation tubing, reusableA length of flexible noninvasive tube, typically made of synthetic polymer material(s), intended to interface between suction and/or irrigation devices (e.g., catheters, pumps, collection bottles) during a medical/surgical procedure (not dedicated to ophthalmic use); it might additionally be intended for use during reusable device reprocessing. The tubing may be provided in rolls from which required lengths are cut, or may be provided in predetermined lengths with connectors; it does not include additional associated items such as a clamp, spike, or bag (i.e., not a tubing set). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
690710546
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

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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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04589551395088Multi Pad2NAKANISHI INC.EBW2026-06-02
08033837935889AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935896AnthosCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935902Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935919Stern WeberCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935926CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08033837935933CastelliniCEFLA SOCIETA' COOPERATIVAEBW2026-04-16
08809260475519X-CUBESaeshin Precision Co., Ltd.EBW2026-04-02
08809260475403AHP-85-SSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475410TRAUSSaeshin Precision Co., Ltd.EBW2026-03-25
08809260475359SDI10Saeshin Precision Co., Ltd.EBW2026-03-04
10194665008444A-decA-DEC, INC.EBW2026-02-19
10194665008475A-decA-DEC, INC.EBW2026-02-19
10194665008482A-decA-DEC, INC.EBW2026-02-19
10194665008499A-decA-DEC, INC.EBW2026-02-19
10194665008505A-decA-DEC, INC.EBW2026-02-19
10194665008512A-decA-DEC, INC.EBW2026-02-19
10194665008529A-decA-DEC, INC.EBW2026-02-19
10194665008550A-decA-DEC, INC.EBW2026-02-19
E27668312130Midwest Motor Control ModuleSIRONA Dental Systems GmbHEBW2026-02-17
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E27668303060Midwest Power Lux MotorSIRONA Dental Systems GmbHEBW2026-02-13
00810126043153SM7 US ( Complete Set )HIOSSEN, INC.EBW2026-01-09
00810126043160S200EML (Contra) Dental Surgery Hand PieceHIOSSEN, INC.EBW2026-01-09
08404535021684ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
08404535021714ForzaPeter Brasseler Holdings, LLCEBW2026-01-09
04589551393381Straumann SGL80MNAKANISHI INC.EBW2026-01-03
04589551393374Straumann Surgical Motor Pro 2NAKANISHI INC.EBW2026-01-03
04589551384082Straumann SGL80MNAKANISHI INC.EBW2026-01-03
J021081659501Dongle for foot control S-NW3W & H Dentalwerk Bürmoos GmbHEBW2025-12-18