ELASTY Mesoneedle

GUDID 38809407784680

Feeltech Co.,Ltd.

Hypodermic needle, single-use

• Primary Device ID: 38809407784680
• NIH Device Record Key: b73bbeb5-e0c4-4a4a-bd95-1fa2fc184ac6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELASTY Mesoneedle
• Version Model Number: ELASTY Mesoneedle 34Gx13mm
• Company DUNS: 688432407
• Company Name: Feeltech Co.,Ltd.
• 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: false
• 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	08809407784689 [Unit of Use]
GS1	18809407784686 [Primary]
GS1	28809407784683 [Package]; Contains: 18809407784686; Package: [1000 Units]; In Commercial Distribution
GS1	38809407784680 [Package]; Contains: 28809407784683; Package: [5000 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K092831

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: 3
• Public Version Date: 2019-10-23
• Device Publish Date: 2019-07-10

On-Brand Devices [ELASTY Mesoneedle]

• 38809407784680: ELASTY Mesoneedle 34Gx13mm
• 38809407784673: ELASTY Mesoneedle 34Gx4mm