AcuZone AZ 1-30125

GUDID B491AZ1301253

Smooth and sharp for painless, AcuZone disposable sterile acupuncture needles are made of high quality surgical stainless steel and the handle is with

Wujiang City ShenLing Medical Device Co.,Ltd

Acupuncture needle, single-use

• Primary Device ID: B491AZ1301253
• NIH Device Record Key: e8701c83-fe84-469b-860f-a41d7a2b7421
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AcuZone
• Version Model Number: AZ 1-30125
• Catalog Number: AZ 1-30125
• Company DUNS: 654613546
• Company Name: Wujiang City ShenLing Medical Device 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 Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B491AZ1301250 [Unit of Use]
HIBCC	B491AZ1301251 [Primary]
HIBCC	B491AZ1301253 [Package]; Contains: B491AZ1301251; Package: [100 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K002411

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2017-12-21

On-Brand Devices [AcuZone]

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