Bosworth Original Truliner 0921942

GUDID H66809219421

Orig Truliner PMMA Standard P&L Kit Clear

Harry J Bosworth Company

Denture reliner, hard

• Primary Device ID: H66809219421
• NIH Device Record Key: 42da7aea-7e47-48c9-8754-9f4fec94b7a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Original Truliner
• Version Model Number: 0921942
• Catalog Number: 0921942
• Company DUNS: 014769301
• Company Name: Harry J Bosworth Company
• 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: 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

Customer Support Contacts

• Phone: +1(800)333-3131
• Email: tschwear@keystoneind.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *Keep away from moisture

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809219421 [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: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-08-09
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Original Truliner]

• H66809219601: Qt Orig Truliner Liquid
• H66809219591: 5 lb Orig Truliner PMMA Pwd Clear
• H66809219581: 5 lb Orig Truliner PMMA Pwd Vein
• H66809219571: 5 lb Orig Truliner PMMA Pwd Pink
• H66809219521: 1 lb bulk Orig Truliner PMMA P&L Kit Vein
• H66809219511: 1 lb bulk Orig Truliner PMMA P&L Kit Pink
• H66809219501: Orig Truliner Liquid
• H66809219481: Orig Truliner PMMA Pwd Vein
• H66809219471: Orig Truliner PMMA Pwd Pink
• H66809219461: Orig Truliner Liquid
• H66809219451: Orig Truliner PMMA Pwd Clear
• H66809219441: Orig Truliner PMMA Pwd Vein
• H66809219431: Orig Truliner PMMA Pwd Pink
• H66809219421: Orig Truliner PMMA Standard P&L Kit Clear
• H66809219411: Orig Truliner PMMA Standard P&L Kit Vein
• H66809219401: Orig Truliner PMMA Standard P&L Kit Pink