EsCom 100 C2 Syringe 101-0710

GUDID 00210205180029

Spident Co., Ltd.

Dental composite resin

• Primary Device ID: 00210205180029
• NIH Device Record Key: f86e8483-b668-47dc-ac3c-ff5e9cd971a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsCom 100 C2 Syringe
• Version Model Number: 101-0710
• Catalog Number: 101-0710
• 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: true
• Lot Batch: true
• Serial Number: true
• 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	00210205180029 [Package]; Contains: 08809262955293; Package: [20 Units]; Discontinued: 2019-06-30; Not in Commercial Distribution
GS1	08809262955293 [Primary]
GS1	20220111190016 [Package]; Contains: 08809262955293; Package: [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K110428

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: 3
• Public Version Date: 2019-07-01
• Device Publish Date: 2018-08-21

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