Eye Cups

GUDID 00616784338002

Eye Cups in Sealed Vial

DYNAREX CORPORATION

Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup Eye wash cup

• Primary Device ID: 00616784338002
• NIH Device Record Key: e157dc79-4f39-4314-9b3c-d9ae46e5299f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Eye Cups
• Version Model Number: 3380
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• 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: 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784338002 [Primary]
GS1	00616784338019 [Package]; Package: Vial [6 Units]; In Commercial Distribution
GS1	00616784338033 [Package]; Contains: 00616784338019; Package: Case [50 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151575

FDA Product Code

• LXQ: Cup, Eye

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: 2022-05-03
• Device Publish Date: 2022-04-25

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• 00840117333024 - XeroBurn Sterile Burn Dressing Blanket 60"x 70": 2024-04-02 60"x 70"
• 00840117333048 - XeroBurn Sterile Burn Dressing Blanket 70" x 95": 2024-04-02 70" x 95"