EpiRite Syringe, w/o Needle, 1cc, Luer Slip, 10/100/Cs

GUDID 00616784698526

DYNAREX CORPORATION

Metered-delivery hypodermic syringe

• Primary Device ID: 00616784698526
• NIH Device Record Key: 45bd386e-d44e-415c-a643-3a7e9a5adc3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EpiRite Syringe, w/o Needle, 1cc, Luer Slip, 10/100/Cs
• Version Model Number: 6985
• 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: 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: true
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784698526 [Primary]
GS1	00616784698533 [Package]; Package: Case [10 Units]; In Commercial Distribution
GS1	00810180840194 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060211

FDA Product Code

• FMF: Syringe, Piston

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-16
• Device Publish Date: 2018-07-16

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