PIEZON MASTER SURGERY DS-104A

GUDID 07613353029821

Instrument SL4 with CT

E.M.S. Electro Medical Systems S.A.

Dental ultrasonic surgical system handpiece tip

• Primary Device ID: 07613353029821
• NIH Device Record Key: 0c24f23c-b02f-4fa7-8f0e-56314cbb7901
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PIEZON MASTER SURGERY
• Version Model Number: C
• Catalog Number: DS-104A
• Company DUNS: 481233849
• Company Name: E.M.S. Electro Medical Systems S.A.
• 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: 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

Customer Support Contacts

• Phone: +41229944700
• Email: udi@ems-ch.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07613353029821 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072146

FDA Product Code

• DZI: Drill, Bone, Powered

Sterilization

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

[07613353029821]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-09-27
• Device Publish Date: 2016-09-08

On-Brand Devices [PIEZON MASTER SURGERY]

• 07613353087524: Extraction System Piezon Master Surgery
• 07613353087487: Basic System Piezon Master Surgery
• 07613353029845: BC instrument with Surgery CombiTorque
• 07613353029821: Instrument SL4 with CT
• 07613353029814: Instrument SL3 with CT
• 07613353029807: Instrument SL 2 with CT
• 07613353029791: Instrument SL1 with Surgery CT
• 07613353029784: Instrument SL1 with Surgery CT
• 07613353029777: Instrument SC with Surgery CT
• 07613353002688: Basic PIEZON MASTER SURGERY
• 07613353002671: Instrument Sinus Lift N°4
• 07613353002664: Instrument SL3
• 07613353002657: Instrument Sinus Lift N°2
• 07613353002640: Instrument Sinus Lift N°1
• 07613353002633: Instrument SC
• 07613353002626: SURGERY MASTER SYSTEM
• 07613353001803: PIEZON SURGERY Handpiece with cord
• 07613353175269: PIEZON SURGERY Handpiece with cord