ARENA Star

GUDID 08800055732985

ARUM DENTISTRY Co., Ltd.

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• Primary Device ID: 08800055732985
• NIH Device Record Key: 72a34fdd-350b-4b56-bce2-72dd84a71900
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARENA Star
• Version Model Number: Arum-WR-28-C2
• Company DUNS: 557821945
• Company Name: ARUM DENTISTRY Co., Ltd.
• 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: true
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800055732985 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223253

FDA Product Code

• DIH: Colorimetry, Cholinesterase

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: 2023-04-10
• Device Publish Date: 2023-03-31

On-Brand Devices [ARENA Star]

• 08800055732008: Arum-WR-10-A2
• 08800055731902: Arum-WR-10-A1
• 08800055731803: Arum-WR-10
• 08800055733494: Arum-WR-30-D4
• 08800055733487: Arum-WR-28-D4
• 08800055733470: Arum-WR-25-D4
• 08800055733463: Arum-WR-22-D4
• 08800055733456: Arum-WR-20-D4
• 08800055733449: Arum-WR-18-D4
• 08800055733432: Arum-WR-16-D4
• 08800055733425: Arum-WR-14-D4
• 08800055733418: Arum-WR-12-D4
• 08800055733401: Arum-WR-10-D4
• 08800055733395: Arum-WR-30-D3
• 08800055733388: Arum-WR-28-D3
• 08800055733371: Arum-WR-25-D3
• 08800055733364: Arum-WR-22-D3
• 08800055733357: Arum-WR-20-D3
• 08800055733340: Arum-WR-18-D3
• 08800055733333: Arum-WR-16-D3
• 08800055733326: Arum-WR-14-D3
• 08800055733319: Arum-WR-12-D3
• 08800055733302: Arum-WR-10-D3
• 08800055733296: Arum-WR-30-D2
• 08800055733289: Arum-WR-28-D2
• 08800055733272: Arum-WR-25-D2
• 08800055733265: Arum-WR-22-D2
• 08800055733258: Arum-WR-20-D2
• 08800055733241: Arum-WR-18-D2
• 08800055733234: Arum-WR-16-D2
• 08800055733227: Arum-WR-14-D2
• 08800055733210: Arum-WR-12-D2
• 08800055733203: Arum-WR-10-D2
• 08800055733197: Arum-WR-30-C4
• 08800055733180: Arum-WR-28-C4
• 08800055733173: Arum-WR-25-C4
• 08800055733166: Arum-WR-22-C4
• 08800055733159: Arum-WR-20-C4
• 08800055733142: Arum-WR-18-C4
• 08800055733135: Arum-WR-16-C4
• 08800055733128: Arum-WR-14-C4
• 08800055733111: Arum-WR-12-C4
• 08800055733104: Arum-WR-10-C4
• 08800055733098: Arum-WR-30-C3
• 08800055733081: Arum-WR-28-C3
• 08800055733074: Arum-WR-25-C3
• 08800055733067: Arum-WR-22-C3
• 08800055733050: Arum-WR-20-C3
• 08800055733043: Arum-WR-18-C3
• 08800055733036: Arum-WR-16-C3