Syringes (w/o needle)

GUDID 00616784699134

DYNAREX CORPORATION

Metered-delivery hypodermic syringe

• Primary Device ID: 00616784699134
• NIH Device Record Key: 2022f415-834d-4fff-ba4f-4d5b1a688d23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Syringes (w/o needle)
• Version Model Number: 6991
• Company DUNS: 008124539
• Company Name: DYNAREX CORPORATION
• Device Count: 50
• 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	00616784699110 [Unit of Use]
GS1	00616784699127 [Primary]
GS1	00616784699134 [Package]; Contains: 00616784699127; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060211

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: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-24

On-Brand Devices [Syringes (w/o needle)]

• 00616784699332: 6993
• 00616784699233: 6992
• 00616784699134: 6991
• 00616784699035: 6990
• 00616784698939: 6989
• 00616784698830: 6988
• 00616784698731: 6987