GUDID 06974813830069

standard tool holder

Sinovation (Beijing) Medical Technology Co., Ltd

Neurological stereotactic surgery system

• Primary Device ID: 06974813830069
• NIH Device Record Key: b364f380-4592-40b1-a766-b3d575e0c034
• Commercial Distribution Status: In Commercial Distribution
• Version Model Number: 37100003
• 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	06974813830069 [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

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

Moist Heat or Steam Sterilization

[06974813830069]

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: 2023-09-08standard tool holder
• 06974813830069 - NA: 2023-09-08 standard tool holder
• 06974813830076 - NA: 2023-09-08 Pointer probe
• 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,