Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

GUDID 00348783011487

INSTRUMENT CASSETTE MARK I

PREMIER DENTAL PRODUCTS COMPANY

Device sterilization/disinfection container, reusable

• Primary Device ID: 00348783011487
• NIH Device Record Key: c4273b5e-8343-41a1-a170-18fa4d8a2728
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
• Version Model Number: 9010904
• 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: false
• 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	00348783011487 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K972138

FDA Product Code

• FRG: Wrap, Sterilization

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

[00348783011487]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 8
• Public Version Date: 2024-09-27
• Device Publish Date: 2016-09-19

On-Brand Devices [Sterilization Wrap Containers, Trays, Cassettes & Other Accessories]

• 00348783011500: INSTRUMENT CASSETTE MARK IV
• 00348783011494: INSTRUMENT CASSETTE MARK VI
• 00348783011487: INSTRUMENT CASSETTE MARK I
• 00348783011470: INSTRUMENT CASSETTE ACCESSORY