EsCom 100 A3 Capsules 101-0603

GUDID 20190723160274

Spident Co., Ltd.

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• Primary Device ID: 20190723160274
• NIH Device Record Key: 1a3d85e0-94d9-488a-81e7-7e28ef7bb8d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EsCom 100 A3 Capsules
• Version Model Number: 101-0603
• Catalog Number: 101-0603
• 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	00000202210276 [Package]; Contains: 08809262955460; Package: [50 Units]; Discontinued: 2022-10-27; In Commercial Distribution
GS1	00000202305057 [Package]; Contains: 08809262955460; Package: [70 Units]; Discontinued: 2023-05-05; In Commercial Distribution
GS1	00202202250089 [Package]; Contains: 08809262955460; Package: [140 Units]; In Commercial Distribution
GS1	00220305190231 [Package]; Contains: 08809262955460; Package: [140 Units]; Discontinued: 2021-01-25; Not in Commercial Distribution
GS1	08809262955460 [Primary]
GS1	20190723160274 [Package]; Contains: 08809262955460; Package: [300 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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