Safety Syringe w/Needle

GUDID 00616784691633

DYNAREX CORPORATION

Metered-delivery hypodermic syringe/needle

• Primary Device ID: 00616784691633
• NIH Device Record Key: d6883718-ea45-486b-aeb2-deb3307eefd5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Safety Syringe w/Needle
• Version Model Number: 6916
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784691619 [Unit of Use]
GS1	00616784691626 [Primary]
GS1	00616784691633 [Package]; Contains: 00616784691626; Package: [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031594

FDA Product Code

• MEG: Syringe, Antistick

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Safety Syringe w/Needle]

• 00616784693033: 6930
• 00616784692937: 6929
• 00616784692838: 6928
• 00616784692739: 6927
• 00616784692630: 6926
• 00616784692531: 6925
• 00616784692432: 6924
• 00616784692333: 6923
• 00616784692234: 6922
• 00616784692135: 6921
• 00616784692036: 6920
• 00616784691930: 6919
• 00616784691831: 6918
• 00616784691732: 6917
• 00616784691633: 6916
• 00616784691534: 6915