Surgical Angle Handpiece

GUDID 04560264556263

NAKANISHI INC.

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• Primary Device ID: 04560264556263
• NIH Device Record Key: 1865b006-ff4e-476d-888f-49fe5024bf27
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Surgical Angle Handpiece
• Version Model Number: SGA-ES
• 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: false
• 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	04560264556263 [Primary]
GS1	04560264557321 [Direct Marking]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171155

FDA Product Code

• KMW: Handpiece, Rotary Bone Cutting

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

[04560264556263]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2018-11-22
• Device Publish Date: 2018-01-22

On-Brand Devices [Surgical Angle Handpiece]

• 04560264556287: SGA-E2S
• 04560264556263: SGA-ES