Hypodermic Needle, Non-Safety, 22G, 3/4" needles

GUDID 00616784698113

DYNAREX CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 00616784698113
• NIH Device Record Key: 3c3200e9-7b31-421b-9386-0c5fd8309c58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypodermic Needle, Non-Safety, 22G, 3/4" needles
• Version Model Number: 6981
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 1000
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• 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	00616784698113 [Primary]
GS1	00616784698137 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180417

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: 4
• Public Version Date: 2020-01-20
• Device Publish Date: 2019-05-06

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