Creliver

GUDID 06950940801981

Shenzhen Osto Technology Co.,Ltd.

Acupuncture electrical stimulation system

• Primary Device ID: 06950940801981
• NIH Device Record Key: 47f9da48-b604-4672-bdff-92804d847f92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Creliver
• Version Model Number: AST-300A
• Company DUNS: 528161684
• Company Name: Shenzhen Osto Technology Co.,Ltd.
• Device Count: 2000
• 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: false
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	06950940801974 [Primary]
GS1	06950940801981 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211736

FDA Product Code

• NGX: Stimulator, Muscle, Powered, For Muscle Conditioning

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-04-08
• Device Publish Date: 2024-03-31

On-Brand Devices [Creliver]

• 06950940801462: AST-905B
• 06950940801769: AST-300T
• 06950940801981: AST-300A
• 06950940802056: AST-623B