Sleeve-It

GUDID 00348783005707

Sleeve-It 100 Series 1.2/3.0 ML-Box 300

PREMIER DENTAL PRODUCTS COMPANY

Glass ionomer dental cement

• Primary Device ID: 00348783005707
• NIH Device Record Key: b7c427a9-b271-4ce3-a000-45139909f8f4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleeve-It
• Version Model Number: 9011501
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• 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	00348783005707 [Primary]
GS1	10348783005704 [Package]; Package: case [25 Units]; In Commercial Distribution

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: 2024-03-19
• Device Publish Date: 2024-03-11

On-Brand Devices [Sleeve-It]

• 00348783005721: Sleeve-It 200 Series 5.0 ML-Sample
• 00348783005714: Sleeve-It 200 Series 5.0 ML-Box 300
• 00348783005707: Sleeve-It 100 Series 1.2/3.0 ML-Box 300
• 00348783005691: Sleeve-It 100 Series 1.2/3.0 ML-Sample Box of 5