SecureSafe Safety Hypodermic Needles

GUDID 00616784897622

DYNAREX CORPORATION

Hypodermic needle, single-use

• Primary Device ID: 00616784897622
• NIH Device Record Key: f6003ab4-11af-4351-acfa-a2fcd17354c6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SecureSafe Safety Hypodermic Needles
• Version Model Number: 8976
• 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	00616784897615 [Unit of Use]
GS1	00616784897622 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142765

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: 2017-10-16

On-Brand Devices [SecureSafe Safety Hypodermic Needles]

• 00616784897622: 8976
• 00616784897523: 8975
• 00616784897424: 8974
• 00616784897325: 8973
• 00616784897226: 8972
• 00616784897127: 8971
• 00616784897028: 8970
• 00616784896922: 8969
• 00616784896823: 8968
• 00616784896724: 8967
• 00616784896625: 8966
• 00616784896526: 8965
• 00616784896427: 8964
• 00616784896328: 8963
• 00616784896229: 8962
• 00616784896120: 8961
• 00061678489627: 8961