FX57

GUDID 04560264578494

NAKANISHI INC.

Surgical instrument maintenance lubricant

Primary Device ID	04560264578494
NIH Device Record Key	bd5d20b5-3464-4a72-bf44-1627bd0c08e0
Commercial Distribution Status	In Commercial Distribution
Brand Name	FX57
Version Model Number	FX57
Company DUNS	690710546
Company Name	NAKANISHI INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04560264578326 [Primary]
GS1	04560264578494 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K222518

FDA Product Code

EGS	Handpiece, contra- and right-angle attachment, dental

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

[04560264578494]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	New
Device Record Status	Published
Public Version Number	1
Public Version Date	2023-03-20
Device Publish Date	2023-03-10

Devices Manufactured by NAKANISHI INC.

04560264575158 - Nozzle Holder	2024-11-25
04560264575165 - Nozzle Holder	2024-11-25
04560264575172 - Internal Spray Nozzle	2024-11-25
04560264575189 - Cleaning Wire	2024-11-25
04560264575271 - Tube Holder	2024-11-25
04560264576506 - Protection Plug	2024-11-25
04560264576513 - Coolant Solution Hanger Post	2024-11-25
04589551392421 - Tube Holder	2024-11-25

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