GUDID 06974813830083

Instrument adaptor

Sinovation (Beijing) Medical Technology Co., Ltd

Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system Neurological stereotactic surgery system

• Primary Device ID: 06974813830083
• NIH Device Record Key: dcacec30-4fbc-4526-8ffe-5fbc983cfe20
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 37100013
• Company DUNS: 560671783
• Company Name: Sinovation (Beijing) Medical Technology Co., Ltd
• Device Count: 1
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	06974813830083 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220072

FDA Product Code

• HAW: Neurological Stereotaxic Instrument

Sterilization

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

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

[06974813830083]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

Devices Manufactured by Sinovation (Beijing) Medical Technology Co., Ltd

• 06974813830045 - NA: 2023-09-08 Optical 3D scanner
• 06974813830069 - NA: 2023-09-08 standard tool holder
• 06974813830076 - NA: 2023-09-08 Pointer probe
• 06974813830083 - NA: 2023-09-08Instrument adaptor
• 06974813830083 - NA: 2023-09-08 Instrument adaptor
• 06974813830113 - NA: 2023-09-08 Instrument adapters
• 06974813830199 - NA: 2023-09-08 Microdrive holder
• 06974813830205 - NA: 2023-09-08 Microdrive holder
• 06974813831363 - NA: 2023-09-08 Sinobot X1 Robotized image-guided interactive surgical equipment (including robotic arm, Display screen, Computer and software,