STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE

GUDID 06971685270153

The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized with ethylene oxide gas. One needle with one tube per sterile, individually blister package, 100 needles per box.

Changchun AIK Medical Devices Co., Ltd.

Acupuncture needle, single-use

• Primary Device ID: 06971685270153
• NIH Device Record Key: 09062a22-db22-4275-80c5-73bbbb0ad13a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STERILE ACUPUNCTURE NEEDLES FOR SINGLE USE
• Version Model Number: 0.20*50
• Company DUNS: 543439762
• Company Name: Changchun AIK Medical Devices 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06971685270153 [Primary]
GS1	16971685272062 [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: 2019-10-03
• Device Publish Date: 2019-09-25

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

• 06971685270511: The AIK Sterile Acupuncture Needles are manufactured from stainless steel and sterilized with et
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