Access Edge

GUDID 00817051020310

Access Edge prefilled retraction paste tips, 60

CENTRIX, INC.

Gingival retraction cord, non-medicated

• Primary Device ID: 00817051020310
• NIH Device Record Key: f80e44c1-973c-425e-b6fe-aa1f9115e585
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Access Edge
• Version Model Number: 360114
• Company DUNS: 053707303
• Company Name: CENTRIX, INC.
• 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: true
• Expiration Date: true
• 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	00817051020310 [Primary]

FDA Product Code

• MVL: Cord, Retraction

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-10-15
• Device Publish Date: 2016-09-23

On-Brand Devices [Access Edge]

• 00817051020310: Access Edge prefilled retraction paste tips, 60
• 00817051020303: Access Edge prefilled retraction paste tips, 15