Fusion DME-01

GUDID 00810038090436

Deep Margin Elevation Kit

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental matrix band kit

• Primary Device ID: 00810038090436
• NIH Device Record Key: a23fdf20-86f0-4356-850e-56f64cf41566
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fusion
• Version Model Number: DME-01
• Catalog Number: DME-01
• Company DUNS: 057647005
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• 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: true
• 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	00810038090436 [Primary]

FDA Product Code

• JEP: Retainer, Matrix

Sterilization

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

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

[00810038090436]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-29
• Device Publish Date: 2022-08-19

On-Brand Devices [Fusion]

• 00810038090443: Deep Margin Elevation Kit
• 00810038090436: Deep Margin Elevation Kit