easydrip Cassic Pen Needles

GUDID 06972857291914

Sandstone Medical (Suzhou) Inc.

Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle Autoinjector needle

• Primary Device ID: 06972857291914
• NIH Device Record Key: 61e51e46-ce33-4842-892a-3f523c2e5df4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: easydrip Cassic Pen Needles
• Version Model Number: 01-3105
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06972857291914 [Unit of Use]
GS1	16972857291911 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193422

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: 2023-07-28
• Device Publish Date: 2023-07-20

Devices Manufactured by Sandstone Medical (Suzhou) Inc.

• 06972857292928 - EasyDrip Pen Needles 32G 4mm: 2024-01-23
• 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