easydrip ReadyGard Duo Safety Pen Needles

GUDID 36972857291236

Sandstone Medical (Suzhou) Inc.

Autoinjector needle

• Primary Device ID: 36972857291236
• NIH Device Record Key: 029a338f-0ede-41cc-840e-c24cb52e8547
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easydrip ReadyGard Duo Safety Pen Needles
• Version Model Number: 05-3005
• Company DUNS: 554500882
• Company Name: Sandstone Medical (Suzhou) Inc.
• 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	06972857291235 [Unit of Use]
GS1	16972857291232 [Primary]
GS1	36972857291236 [Package]; Contains: 16972857291232; Package: [8 Units]; Discontinued: 2023-02-07; Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210864

FDA Product Code

• FMI: Needle, Hypodermic, Single Lumen

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-02-15
• Device Publish Date: 2023-02-07

On-Brand Devices [easydrip ReadyGard Duo Safety Pen Needles]

• 36972857291236: 05-3005
• 06972857291785: 05-3008
• 36972857292561: 05-3005