EsCom 100 A2 Capsules 101-0602

GUDID 20200723170323

Spident Co., Ltd.

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• Primary Device ID: 20200723170323
• NIH Device Record Key: b4741bf8-42bd-4bb0-902a-54ff3acfef6f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsCom 100 A2 Capsules
• Version Model Number: 101-0602
• Catalog Number: 101-0602
• 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	00000202304029 [Package]; Contains: 08809262955446; Package: [200 Units]; Discontinued: 2023-04-02; In Commercial Distribution
GS1	00202201110087 [Package]; Contains: 08809262955446; Package: [160 Units]; In Commercial Distribution
GS1	00220405190339 [Package]; Contains: 08809262955446; Package: [160 Units]; Discontinued: 2021-01-25; Not in Commercial Distribution
GS1	08809262955446 [Primary]
GS1	20200723170323 [Package]; Contains: 08809262955446; Package: [540 Units]; Discontinued: 2019-05-16; Not 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: 2
• Public Version Date: 2019-05-17
• Device Publish Date: 2018-08-23

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