Pen Needles

GUDID 00616784702537

DYNAREX CORPORATION

Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use Hypodermic needle, single-use

• Primary Device ID: 00616784702537
• NIH Device Record Key: e6e19d6e-366f-4d1b-99a7-4967f5bf1d40
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pen Needles
• Version Model Number: 7025
• 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	00616784702513 [Unit of Use]
GS1	00616784702520 [Primary]
GS1	00616784702537 [Package]; Contains: 00616784702520; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131954

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 [Pen Needles]

• 00616784702834: 7028
• 00616784702735: 7027
• 00616784702636: 7026
• 00616784702537: 7025
• 00616784702438: 7024