OSITO

GUDID 06950940801417

Shenzhen Osto Technology Co.,Ltd.

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• Primary Device ID: 06950940801417
• NIH Device Record Key: f2112874-9b9c-4803-b178-8cc677e6a85f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: OSITO
• Version Model Number: AST-301
• 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	06950940801400 [Primary]
GS1	06950940801417 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182136

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: 2020-07-03
• Device Publish Date: 2020-06-25

On-Brand Devices [OSITO]

• 06950940801165: AST-2012A
• 06950940801158: AST-303
• 06950940801394: AST-603
• 06950940801356: AST-300J
• 06950940801417: AST-301
• 06950940801332: AST-300L
• 06950940801448: AST-905B
• 06950940801318: AST-2012B
• 06950940801486: AST-2011B
• 06950940801530: AST-802B
• 06950940801608: AST-2012A
• 06950940801745: AST-905D