YI SHEN BIAN QUE Acupuncture needle

GUDID 26956418969539

Single hand, plastic handle acupuncture needle, one needle with one tube in one blister,100pcs/box.

Suzhou Huanqiu Acupuncture Medical Appliance Co., Ltd.

Acupuncture needle, single-use

• Primary Device ID: 26956418969539
• NIH Device Record Key: 67433a37-7ef1-4408-b46e-6efc48953bf7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: YI SHEN BIAN QUE Acupuncture needle
• Version Model Number: 0.30×40mm
• Company DUNS: 527023772
• Company Name: Suzhou Huanqiu Acupuncture Medical Appliance 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: 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	06956418969535 [Unit of Use]
GS1	16956418969532 [Primary]
GS1	26956418969539 [Package]; Contains: 16956418969532; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K011242

FDA Product Code

• MQX: Needle, Acupuncture, Single Use

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: 2019-03-25
• Device Publish Date: 2019-03-15

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