DENOPS

GUDID 08800053042093

DC : 3.7 V, 550mh(Battery)

DENTIS CO. ,LTD

Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable Dental anaesthesia syringe, reusable

• Primary Device ID: 08800053042093
• NIH Device Record Key: 80735fac-eef4-40a2-9fcf-d6e1a2169002
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DENOPS
• Version Model Number: AN100
• Company DUNS: 694721181
• Company Name: DENTIS CO. ,LTD
• 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: false
• 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	08800053042093 [Primary]

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: 2024-01-31
• Device Publish Date: 2024-01-23

Devices Manufactured by DENTIS CO. ,LTD

• 08800053091305 - Luvis Chair (LC700C-chair only): 2024-04-03 A Dental Chair to provide patient supporting and positioning during dental treatment.
• 08806169138965 - s-Clean Ratchet Driver: 2024-04-02 s-Clean Ratchet Driver (DRMDSEL)
• 08800053082808 - MESHEET075: 2024-03-13 MESHEET075
• 08800053082815 - MESHEET075-R: 2024-03-13
• 08800053042093 - DENOPS: 2024-01-31DC : 3.7 V, 550mh(Battery)
• 08800053042093 - DENOPS: 2024-01-31 DC : 3.7 V, 550mh(Battery)
• 08800053045032 - LUVIS-C600 Series: 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
• 08800053045049 - LUVIS-C600 Series: 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA
• 08800053045056 - LUVIS-C600 Series: 2024-01-31 AC 100-240 V, 50-60 Hz, 30-45 VA