Feelsoft Micro Needles

GUDID 28809407787677

Feeltech Co.,Ltd.

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: 28809407787677
• NIH Device Record Key: ab0dcf7c-61ef-490b-831b-20742828e13b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Feelsoft Micro Needles
• Version Model Number: Feelsoft Micro Mesoneedles 33Gx4mm
• 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	08809407787673 [Unit of Use]
GS1	18809407787670 [Primary]
GS1	28809407787677 [Package]; Contains: 18809407787670; Package: OUTBOX [800 Units]; In Commercial Distribution
GS1	38809407787674 [Package]; Package: CARTONBOX [4000 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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-04
• Device Publish Date: 2020-07-27

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