SecureSafe Safety Insulin Syringe

GUDID 00616784890227

DYNAREX CORPORATION

Insulin syringe/needle, safety

• Primary Device ID: 00616784890227
• NIH Device Record Key: 15ddb412-632b-4387-8c1f-23a788acd7e0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureSafe Safety Insulin Syringe
• Version Model Number: 8902
• 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: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784890210 [Unit of Use]
GS1	00616784890227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150758
• Premarket Notification: K191639

FDA Product Code

• FMF: Syringe, Piston
• 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: 2017-10-16

On-Brand Devices [SecureSafe Safety Insulin Syringe]

• 00616784890524: 8905
• 00616784890425: 8904
• 00616784890326: 8903
• 00616784890227: 8902
• 00616784890128: 8901