SecureSafe Syringe With Safety Needle

GUDID 00616784892825

DYNAREX CORPORATION

Insulin syringe/needle, safety

• Primary Device ID: 00616784892825
• NIH Device Record Key: 57b86bda-352e-44ab-82d9-51b78eb22cd4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureSafe Syringe With Safety Needle
• Version Model Number: 8928
• 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	00616784892818 [Unit of Use]
GS1	00616784892825 [Primary]
GS1	00616784892832 [Package]; Package: Case [8 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132553

FDA Product Code

• FMF: Syringe, Piston

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: 2019-03-04
• Device Publish Date: 2017-10-16

On-Brand Devices [SecureSafe Syringe With Safety Needle]

• 00616784893228: 8932
• 00616784893129: 8931
• 00616784893020: 8930
• 00616784892924: 8929
• 00616784892825: 8928
• 00616784892726: 8927
• 00616784892627: 8926
• 00616784892528: 8925
• 00616784892320: 8923
• 00616784892122: 8921
• 00616784892023: 8920
• 00616784891729: 8917
• 00616784891620: 8916
• 00616784891521: 8915