EasyDrip ReadyGard Duo Safety Pen Needles 31G 5mm

GUDID 36972857293018

Sandstone Medical (Suzhou) Inc.

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• Primary Device ID: 36972857293018
• NIH Device Record Key: 4d2d9904-221b-4d0e-9643-e6ed0faab8d5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EasyDrip ReadyGard Duo Safety Pen Needles 31G 5mm
• Version Model Number: 05-3105
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972857293017 [Unit of Use]
GS1	16972857293014 [Primary]
GS1	36972857293018 [Package]; Contains: 16972857293014; Package: [8 Units]; 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: 2024-01-23
• Device Publish Date: 2024-01-15

Devices Manufactured by Sandstone Medical (Suzhou) Inc.

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• 36972857292936 - EasyDrip Pen Needles 30G 5mm: 2024-01-23
• 36972857292943 - EasyDrip Pen Needles 30G 8mm: 2024-01-23
• 36972857292950 - EasyDrip Pen Needles 30G 6mm: 2024-01-23
• 36972857292967 - EasyDrip Plus Pen Needles 32G 4mm: 2024-01-23
• 36972857292974 - EasyDrip Plus Pen Needles 30G 5mm: 2024-01-23
• 36972857292981 - EasyDrip Plus Pen Needles 31G 5mm: 2024-01-23
• 36972857292998 - EasyDrip Plus Pen Needles 30G 8mm: 2024-01-23