TissuePro™ Distal Sleeve, MN Retractor Single-Use

GUDID 00860013984632

Armor Dental Corp.

Hand-held dental retractor

• Primary Device ID: 00860013984632
• NIH Device Record Key: c53cb65d-170f-429e-921f-964f50ff0ec3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TissuePro™ Distal Sleeve, MN Retractor Single-Use
• Version Model Number: 83209-SPU
• Company DUNS: 035988858
• Company Name: Armor Dental Corp.
• 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: false
• 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	00860013984632 [Primary]

FDA Product Code

• EIF: Accessories, Retractor, Dental

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: 2025-05-20
• Device Publish Date: 2025-05-12

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• 00860013984601 - TissuePro™ Distal Sleeve, MN Retractor: 2025-05-20
• 00860013984618 - TissuePro™ Proximal Sleeve, MN Retractor: 2025-05-20
• 00860013984625 - TissuePro™ Single Sleeve, MN Retractor: 2025-05-20