VarioSurg

GUDID 04560264563827

NAKANISHI INC.

Dental ultrasonic surgical system handpiece tip

• Primary Device ID: 04560264563827
• NIH Device Record Key: e5fa7a7e-5c7c-4396-abb1-f848446d8dc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VarioSurg
• Version Model Number: SCL5
• Company DUNS: 690710546
• Company Name: NAKANISHI INC.
• Device Count: 1
• DM Exempt: true
• 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: true
• Serial Number: false
• 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	04560264563827 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073678

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264563827]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-08-22
• Device Publish Date: 2016-09-16

On-Brand Devices [VarioSurg]

• 04560264563957: H-SG8L
• 04560264563940: H-SG8R
• 04560264563933: SG68
• 04560264563902: SCL4D
• 04560264563896: SCL2D
• 04560264563872: SCL3
• 04560264563865: SCL1D
• 04560264563858: SCL1
• 04560264563841: H-SG1
• 04560264563834: SCL5D
• 04560264563827: SCL5
• 04560264563810: SCL3D
• 04560264563803: H-SG8
• 04560264563797: SG58
• 04560264563674: VarioSurg Unit
• 04560264563667: VarioSurg Unit
• 04560264563650: VarioSurg Unit
• 04560264563643: SG8A
• 04560264563636: SG1A
• 04560264563605: SG30
• 04560264563599: SG18L
• 04560264563582: SG18R
• 04560264563575: SG15D
• 04560264563568: SG15C
• 04560264563124: V10-S
• 04560264563117: SG19
• 04560264563100: SG17
• 04560264563094: SG16B
• 04560264563087: SG16A
• 04560264563070: SG15B
• 04560264563063: SG15A
• 04560264562936: SG14L
• 04560264562929: SG14R
• 04560264562912: E32D-S
• 04560264562905: E31D-S
• 04560264562899: E30LD-S
• 04560264562882: E30RD-S
• 04560264562875: P25L-S
• 04560264562868: P25R-S
• 04560264562851: P20-S
• 04560264562844: G1-S
• 04560264562837: SG11
• 04560264562820: SG10
• 04560264562813: SG9
• 04560264562806: SG8
• 04560264562790: SG7D
• 04560264562783: SG6D
• 04560264562776: SG5
• 04560264562769: SG4
• 04560264562752: SG3