Health-Tec Barrier Film 660-HT46B

GUDID D773660HT46B1

Health-Tec Barrier Film, 4" x 6" Blue

Dental Health Products Inc

Instrument/equipment drape, single-use, non-sterile Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: D773660HT46B1
• NIH Device Record Key: d4258480-1c18-43e8-8173-040103e2c9cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec Barrier Film
• Version Model Number: 660-HT46B
• Catalog Number: 660-HT46B
• Company DUNS: 623191194
• Company Name: Dental Health Products Inc
• Device Count: 1200
• 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: false
• Serial Number: false
• Manufacturing Date: true
• 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: 800-626-2163
• Email: mhull@dhpi.net
• Phone: 800-626-2163
• Email: mhull@dhpi.net

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D773660HT46B0 [Unit of Use]
HIBCC	D773660HT46B1 [Primary]
HIBCC	D773660HT46B3 [Package]; Package: [12 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160232

FDA Product Code

• PEM: Dental Barriers And Sleeves

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: 2017-01-18

On-Brand Devices [Health-Tec Barrier Film]

• D773660HT46C1: Health-Tec Barrier Film, 4" x 6", Clear
• D773660HT46B1: Health-Tec Barrier Film, 4" x 6" Blue