STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE

GUDID 06971685274113

The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized by gamma-rays radiation. Ten needles with one tube per sterile, individually packed a pouch, 500 needles per box.

Changchun AIK Medical Devices Co., Ltd.

Acupuncture needle, single-use

• Primary Device ID: 06971685274113
• NIH Device Record Key: 89ac04ee-3edb-4337-bce9-2d95e958d09f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
• Version Model Number: 0.18*25
• Company DUNS: 543439762
• Company Name: Changchun AIK Medical Devices Co., Ltd.
• Device Count: 500
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971685274113 [Primary]
GS1	16971685271102 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162566

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: 2019-10-08
• Device Publish Date: 2019-09-30

On-Brand Devices [STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE]

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