Comfortview Retractor 9061393

GUDID 00348783005011

Comfortview Retractor Small (2 pcs)

PREMIER DENTAL PRODUCTS COMPANY

Dental cheek retractor, professional, reusable

• Primary Device ID: 00348783005011
• NIH Device Record Key: c5cd88d7-dbc4-450f-92de-35af3549abe1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Comfortview Retractor
• Version Model Number: 9061383
• Catalog Number: 9061393
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• 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	00348783004991 [Package]; Package: 2 pcs [2 Units]; In Commercial Distribution
GS1	00348783005011 [Primary]

FDA Product Code

• EIG: Retractor, All Types

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: 2024-08-14
• Device Publish Date: 2024-08-06

On-Brand Devices [Comfortview Retractor]

• 00348783005011: Comfortview Retractor Small (2 pcs)
• 00348783004984: Comfortview Retractor (2 pcs)