Sleeve-It

GUDID 00348783005691

Sleeve-It 100 Series 1.2/3.0 ML-Sample Box of 5

PREMIER DENTAL PRODUCTS COMPANY

Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement Glass ionomer dental cement

• Primary Device ID: 00348783005691
• NIH Device Record Key: 44dc9a0e-33f8-40a9-8f93-3b428d909e54
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sleeve-It
• Version Model Number: 9011511
• 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	00348783005691 [Primary]
GS1	10348783005698 [Package]; Package: case [2000 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