SleeperOne 5 SO-5C

GUDID 03760349809913

1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)

DENTALHITEC

Dental computer assisted anaesthesia injection unit

• Primary Device ID: 03760349809913
• NIH Device Record Key: 47cb199b-b679-45a4-84ff-dd04116f3eb6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SleeperOne 5
• Version Model Number: SO_5C
• Catalog Number: SO-5C
• Company DUNS: 640616736
• Company Name: DENTALHITEC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• 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	03760349803331 [Primary]
GS1	03760349809913 [Direct Marking]

FDA Product Code

• EJI: Syringe, Cartridge

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-30
• Device Publish Date: 2023-08-22

Devices Manufactured by DENTALHITEC

• 03760349800507 - EFFITEC NEEDLE 30G EXTRA SHORT: 2023-08-30 1 box of 100 single use needles 30G 9mm
• 03760349800514 - EFFITEC NEEDLE 27G SHORT: 2023-08-30 1 box of 100 single use needles 27G 16mm
• 03760349800521 - EFFITEC NEEDLE 30G SHORT: 2023-08-30 1 box of 100 single use needles 30G 16mm
• 03760349809913 - SleeperOne 5: 2023-08-301 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes of dental needles C3022 (primary DI Number: 03760349800507) 1 box of dental needles C3025 (primary DI Number: 03760349800521)
• 03760349809913 - SleeperOne 5: 2023-08-30 1 SleeperOne 5 handpiece and control box 1 wireless pedal 1 battery charger 1 power supply, 10 containers 1 user manual 2 boxes
• 03760349809951 - Soan: 2023-08-30 1 Soan handpiece 1 wireless pedal 1 battery charger 1 power supply, 5 containers 1 user manual 2 boxes of dental needles C3022