Cosmedent 409200

GUDID D77940920017

COSMEDENT, INC.

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• Primary Device ID: D77940920017
• NIH Device Record Key: 5a204c12-7fb2-43b9-9387-97d14171b026
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cosmedent
• Version Model Number: Full Contact Starter Kit
• Catalog Number: 409200
• Company DUNS: 113911689
• Company Name: COSMEDENT, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	D77940920017 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

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: 2021-06-14
• Device Publish Date: 2021-06-04

Devices Manufactured by COSMEDENT, INC.

• D7796722B01 - Bulkfill: 2022-03-16
• D7796722C31 - Bulkfill: 2022-03-16
• D7796722D21 - Bulkfill: 2022-03-16
• D7796722351 - Bulkfill: 2022-03-09
• D7796722A11 - Bulkfill: 2022-03-09
• D7796722A21 - Bulkfill: 2022-03-09
• D7796722A31 - Bulkfill: 2022-03-09
• D7796722B11 - Bulkfill: 2022-03-09