Tuberculin Syringe

GUDID 00616784693828

DYNAREX CORPORATION

Metered-delivery hypodermic syringe Metered-delivery hypodermic syringe

• Primary Device ID: 00616784693828
• NIH Device Record Key: d250f5ce-44bf-470b-bdc0-aaff77ed8c87
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tuberculin Syringe
• Version Model Number: 6938
• 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	00616784693811 [Unit of Use]
GS1	00616784693828 [Primary]
GS1	00616784693835 [Package]; Package: Case [1000 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: 4
• Public Version Date: 2018-08-09
• Device Publish Date: 2017-10-10

On-Brand Devices [Tuberculin Syringe]

• 00616784693927: 6939
• 00616784693828: 6938
• 00616784693729: 6937