HI-I 09033-006P

GUDID B71509033006P0

Special Grain #3 SF HI-I® LW

FRICKE INTERNATIONAL, INC.

Dental appliance fabrication material, cured

• Primary Device ID: B71509033006P0
• NIH Device Record Key: 5add006a-8e07-4b14-9329-9a417f78605a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HI-I
• Version Model Number: 09033-006P
• Catalog Number: 09033-006P
• Company DUNS: 957630726
• Company Name: FRICKE INTERNATIONAL, 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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: 630-540-1900
• Email: customerservice@frickedental.c
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com

Device Dimensions

• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound
• Weight: 6 Pound

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B71509033006P0 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

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: 2019-04-23
• Device Publish Date: 2019-04-15

On-Brand Devices [HI-I]

• B71513023025P0: Special Fibered #1 "LE" HI-I® Pour
• B71509033006P0: Special Grain #3 SF HI-I® LW
• B71513023006P0: Special Fibered #1 "LE" HI-I® Pour
• B71509032001P0: Special Grain #2 SF HI-I® LW
• B71509032006P0: Special Grain #2 SF HI-I® LW