EsFlow LV A3 Syringe 101-0903

GUDID 20200723170026

Spident Co., Ltd.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin

• Primary Device ID: 20200723170026
• NIH Device Record Key: a5c7c8e1-bf22-47c7-bf34-a13d0f6a57cf
• Commercial Distribution Discontinuation: 2021-01-25
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: EsFlow LV A3 Syringe
• Version Model Number: 101-0903
• Catalog Number: 101-0903
• Company DUNS: 689370711
• Company Name: Spident 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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	08809262954647 [Primary]
GS1	20200723170026 [Package]; Contains: 08809262954647; Package: [15 Units]; Discontinued: 2021-01-25; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K120768

FDA Product Code

• EBF: Material, Tooth Shade, Resin

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2021-01-26
• Device Publish Date: 2018-08-23

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