Bosworth Fastray LC 0921406

GUDID H66809214061

Fastray LC Standard Kit Pink

Harry J Bosworth Company

Dental impression tray material

• Primary Device ID: H66809214061
• NIH Device Record Key: b28da4c0-3b45-4734-9755-b30cf8749111
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Bosworth Fastray LC
• Version Model Number: 0921406
• Catalog Number: 0921406
• Company DUNS: 014769301
• Company Name: Harry J Bosworth Company
• Device Count: 50
• 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: true
• 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

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	H66809214060 [Unit of Use]
HIBCC	H66809214061 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K991631

FDA Product Code

• ELW: MATERIAL, IMPRESSION

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: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [Bosworth Fastray LC]

• H66809214071: Fastray LC Standard Kit White
• H66809214061: Fastray LC Standard Kit Pink
• H66809214051: Fastray LC Standard Kit Blue