Hypodermic Needle

GUDID 00616784697031

DYNAREX CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 00616784697031
• NIH Device Record Key: 63852d58-7e6b-4c7f-a572-35ecbe66c46f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hypodermic Needle
• Version Model Number: 6970
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00616784697017 [Unit of Use]
GS1	00616784697024 [Primary]
GS1	00616784697031 [Package]; Contains: 00616784697024; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K112057

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-10-23
• Device Publish Date: 2016-09-24

On-Brand Devices [Hypodermic Needle]

• 00616784697635: 6976
• 00616784697536: 6975
• 00616784697437: 6974
• 00616784697338: 6973
• 00616784697239: 6972
• 00616784697130: 6971
• 00616784697031: 6970
• 00616784696935: 6969
• 00616784696836: 6968
• 00616784696737: 6967
• 00616784696638: 6966
• 00616784696539: 6965
• 00616784696430: 6964
• 00616784696331: 6963
• 00616784696232: 6962
• 00616784696133: 6961
• 00616784696034: 6960