Disposable Fluoride Trays Large 23710

GUDID 00310866001463

Disposable fluoride trays for administering fluoride gel treatment, large, 100

PASCAL COMPANY, INC.

Fluoride gel tray

• Primary Device ID: 00310866001463
• NIH Device Record Key: 2f58c5b4-5e51-4dd8-b80d-92b32e925746
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Disposable Fluoride Trays Large
• Version Model Number: 23710
• Catalog Number: 23710
• Company DUNS: 009260217
• Company Name: PASCAL COMPANY, INC.
• Device Count: 100
• DM Exempt: false
• Pre-market Exempt: true
• 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: 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8004268051
• Email: pascal@pascaldental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00310866001463 [Primary]
GS1	00310866001951 [Unit of Use]

FDA Product Code

• KMT: Tray, Fluoride, Disposable

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: 2019-03-04
• Device Publish Date: 2019-01-31

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