DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"

GUDID 00810180840163

Dynarex Corporation

General-purpose absorbent tip applicator/swab, single-use

• Primary Device ID: 00810180840163
• NIH Device Record Key: bef025bf-acce-4c32-a5f9-6f1ace8c8c1b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DynaSafety Cotton-Tipped Applicators in Sealed Vial,3"
• Version Model Number: 4307
• Company DUNS: 008124539
• Company Name: Dynarex Corporation
• Device Count: 100
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784430713 [Primary]
GS1	00616784430737 [Package]; Contains: 00616784430713; Package: Case [50 Units]; In Commercial Distribution
GS1	00810180840163 [Unit of Use]

FDA Product Code

• KXF: Applicator, Absorbent Tipped, Non-Sterile

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: 2024-11-19
• Device Publish Date: 2024-11-11

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