Health-Tec X-Ray Head Sleeves 660-HT1526

GUDID D773660HT15261

Health-Tec X-Ray Head Sleeves, 15" x 26"

Dental Health Products Inc

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

• Primary Device ID: D773660HT15261
• NIH Device Record Key: 375a8241-8461-483b-ab64-7a992e542008
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Health-Tec X-Ray Head Sleeves
• Version Model Number: 660-HT1526
• Catalog Number: 660-HT1526
• Company DUNS: 623191194
• Company Name: Dental Health Products Inc
• Device Count: 250
• 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	D773660HT15260 [Unit of Use]
HIBCC	D773660HT15261 [Primary]
HIBCC	D773660HT15263H [Package]; Package: [4 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: 2017-01-24

Devices Manufactured by Dental Health Products Inc

• D7735901000721 - DHP/Health-Tec Sterilization Tape: 2023-04-03 DHP/Health-Tec Sterilization Tape 3/4" x 60 yard
• D7735901000821 - DHP/Health-Tec Sterilization Tape: 2023-04-03 DHP/Health-Tec Sterilization Tape 1" x 60 yard
• D7736001000320 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 DHP/Health-Tec Sterilization Pouches, 2.5" x 4" 200/box
• D7736001000420 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 2.75" x 9" 200/box
• D7736001000520 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 3.5" x 5.25"
• D7736001000620 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 3.5" x 9" 200/box
• D7736001000720 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 3.5" x 9", 500/box
• D7736001000820 - DHP/Health-Tec Sterilization Pouches: 2023-03-31 Health-Tec Sterilization Pouches, 5.25" x 10" 200/box