Tai Chi™ Single AY8123

GUDID 36970514320275

Sterile, disposable, surgical stainless steel Chinese style acupuncture needles with spiral wound silver plated copper handle. One needle with one ins

Suzhou Shenlong Medical Apparatus Co., Ltd.

Acupuncture needle, single-use

• Primary Device ID: 36970514320275
• NIH Device Record Key: 0f9b6f7b-22eb-4a1d-aa9d-0f497903ed4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tai Chi™ Single
• Version Model Number: AY8123
• Catalog Number: AY8123
• Company DUNS: 545745192
• Company Name: Suzhou Shenlong Medical Apparatus 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-722-8775
• Email: customerservice@lhasaoms.com
• Phone: 800-722-8775
• Email: customerservice@lhasaoms.com

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	06970514320274 [Unit of Use]
GS1	16970514320271 [Primary]
GS1	36970514320275 [Package]; Contains: 16970514320271; Package: Case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K023787

FDA Product Code

• MQX: Needle, Acupuncture, Single Use

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: 2018-07-06
• Device Publish Date: 2016-07-26

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