SecureSafe Safety Hyperdermic Needles

GUDID 00616784896021

DYNAREX CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 00616784896021
• NIH Device Record Key: f09f872e-ecf0-42e3-be1d-053f53b3d339
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureSafe Safety Hyperdermic Needles
• Version Model Number: 8960
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 100
• 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	00616784896014 [Unit of Use]
GS1	00616784896021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142765

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2017-10-16

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