SecureSafe Syringes With Safety Needle

GUDID 00616784892429

DYNAREX CORPORATION

Insulin syringe/needle, safety

• Primary Device ID: 00616784892429
• NIH Device Record Key: 043c0052-2c64-41e8-b17d-7e02df6ab85d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureSafe Syringes With Safety Needle
• Version Model Number: 8924
• 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	00616784892412 [Unit of Use]
GS1	00616784892429 [Primary]

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: 2017-10-11

On-Brand Devices [SecureSafe Syringes With Safety Needle]

• 00616784892429: 8924
• 00616784892221: 8922
• 00616784891927: 8919
• 00616784891828: 8918