Acclean 5703906

GUDID 00304040186725

HENRY SCHEIN, INC.

Medical equipment/instrument drape, single-use

• Primary Device ID: 00304040186725
• NIH Device Record Key: 5051d117-f999-442f-99e3-0bc0455f1113
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Acclean
• Version Model Number: 5703906
• Catalog Number: 5703906
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 500
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040186725 [Unit of Use]
GS1	10304040186722 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233918

FDA Product Code

• PEM: Dental barriers and sleeves

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: 2024-10-10
• Device Publish Date: 2024-10-02

Devices Manufactured by HENRY SCHEIN, INC.

• 00304040188156 - Criterion: 2024-12-09 Criterion Nitrl Low Derma Aloe X-Small
• 00304040188163 - Criterion: 2024-12-09 Criterion Nitrl Low Derma Aloe Small
• 00304040188170 - Criterion: 2024-12-09 Criterion Nitrl Low Derma Aloe Medium
• 00304040188187 - Criterion: 2024-12-09 Criterion Nitrl Low Derma Aloe Large
• 00304040188194 - Criterion: 2024-12-09 Criterion Nitrl Low Derma Aloe X-Large
• 00304040188385 - Criterion: 2024-12-09 Criterion Nitrile N100 Glv X-Small-YTY
• 00304040188392 - Criterion: 2024-12-09 Criterion Nitrile N100 Glv Small-YTY
• 00304040188408 - Criterion: 2024-12-09 Criterion Nitrile N100 Glv Medium-YTY