Varios

GUDID 04560264560581

NAKANISHI INC.

Ultrasonic dental scaling/debridement system

• Primary Device ID: 04560264560581
• NIH Device Record Key: 564689f6-32a5-46c7-a32e-d94a618baad2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Varios
• Version Model Number: VA970 (120V)
• 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	04560264560581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113530

FDA Product Code

• ELC: Scaler, ultrasonic

Sterilization

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

[04560264560581]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Varios]

• 04560264563766: V10-E
• 04560264563759: V-P26L
• 04560264563742: V-P26R
• 04560264563704: G9
• 04560264563698: P11L
• 04560264563681: P11R
• 04560264563629: P26L
• 04560264563612: P26R
• 04560264563544: E12
• 04560264563537: E11
• 04560264563520: V-S33
• 04560264563513: V-S3
• 04560264563506: V-S1
• 04560264563490: V-N51
• 04560264563483: V-N50
• 04560264563476: V-S53
• 04560264563469: V-S52
• 04560264563452: V-S51
• 04560264563445: V-S50
• 04560264563438: G28
• 04560264563421: G26
• 04560264563414: G25
• 04560264563407: G22
• 04560264563391: G21
• 04560264563384: E8
• 04560264563377: E7
• 04560264563360: E6
• 04560264563353: E5
• 04560264563346: E4
• 04560264563322: P41
• 04560264563315: P40
• 04560264563308: P25L
• 04560264563292: P25R
• 04560264563285: P21L
• 04560264563278: P21R
• 04560264563018: P20
• 04560264563551: P10
• 04560264563247: P1
• 04560264563230: G13
• 04560264563223: G12
• 04560264563216: G11
• 04560264563209: G6
• 04560264563193: G5
• 04560264563186: G4
• 04560264563179: G3
• 04560264563162: G2
• 04560264563155: G1
• 04560264563148: G8
• 04560264562714: U files 33mm ISO 35
• 04560264562707: U files 33mm ISO 30