Tai Chi™ Power 80 AY71012

GUDID 36970514320022

Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Tai Chi™ Power 80 needles provide practitioners with a high

Suzhou Shenlong Medical Apparatus Co., Ltd.

Acupuncture needle, single-use

• Primary Device ID: 36970514320022
• NIH Device Record Key: b1e64da1-7de1-476b-b3ff-b3367adb0df6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tai Chi™ Power 80
• Version Model Number: AY7102
• Catalog Number: AY71012
• Company DUNS: 545745192
• Company Name: Suzhou Shenlong Medical Apparatus Co., Ltd.
• Device Count: 80
• 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	06970514320021 [Unit of Use]
GS1	16970514320028 [Primary]
GS1	36970514320022 [Package]; Contains: 16970514320028; 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: 2016-07-22

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• 36970514320022: Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Tai
• 16970514320011: Painless Tai Chi™ needles, in economical bulk packaging. Made of surgical stainless steel, Tai