NOVA Minimally Invasive System

GUDID 04718005156818

Poly Axial Screw

BAUI BIOTECH CO. LTD.

Bone-screw internal spinal fixation system, sterile

• Primary Device ID: 04718005156818
• NIH Device Record Key: 719acdf3-5190-453c-a038-27deb1def664
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NOVA Minimally Invasive System
• Version Model Number: 663-7045C
• Company DUNS: 656775504
• Company Name: BAUI BIOTECH 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: 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 Identifiers

Device Issuing Agency	Device ID
GS1	04718005156818 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182416

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

[04718005156818]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-11-10
• Device Publish Date: 2020-11-02

On-Brand Devices [NOVA Minimally Invasive System]

• 04718005156344: Poly Axial Screw
• 04718005156337: Poly Axial Screw
• 04718005156320: Poly Axial Screw
• 04718005156313: Poly Axial Screw
• 04718005156306: Poly Axial Screw
• 04718005156290: Poly Axial Screw
• 04718005156283: Poly Axial Screw
• 04718005156276: Poly Axial Screw
• 04718005156269: Poly Axial Screw
• 04718005156252: Poly Axial Screw
• 04718005156245: Poly Axial Screw
• 04718005156238: Poly Axial Screw
• 04718005156221: Poly Axial Screw
• 04718005156214: Poly Axial Screw
• 04718005156207: Poly Axial Screw
• 04718005156191: Poly Axial Screw
• 04718005156184: Poly Axial Screw
• 04718005156177: Poly Axial Screw
• 04718005156160: Poly Axial Screw
• 04718005156153: Poly Axial Screw
• 04718005156146: Poly Axial Screw
• 04718005156139: Poly Axial Screw
• 04718005156122: Poly Axial Screw
• 04718005156115: Poly Axial Screw
• 04718005156108: Poly Axial Screw
• 04718005156092: Poly Axial Screw
• 04718005156467: Poly Axial Screw
• 04718005156450: Poly Axial Screw
• 04718005156443: Poly Axial Screw
• 04718005156436: Poly Axial Screw
• 04718005156429: Poly Axial Screw
• 04718005156412: Poly Axial Screw
• 04718005156405: Poly Axial Screw
• 04718005156399: Poly Axial Screw
• 04718005156382: Poly Axial Screw
• 04718005156375: Poly Axial Screw
• 04718005156368: Poly Axial Screw
• 04718005156351: Poly Axial Screw
• 04718005156849: Poly Axial Screw
• 04718005156832: Poly Axial Screw
• 04718005156825: Poly Axial Screw
• 04718005156818: Poly Axial Screw
• 04718005156801: Poly Axial Screw
• 04718005156795: Poly Axial Screw
• 04718005156788: Poly Axial Screw
• 04718005156771: Poly Axial Screw
• 04718005156764: Poly Axial Screw
• 04718005156757: Poly Axial Screw
• 04718005156740: Poly Axial Screw
• 04718005156733: Poly Axial Screw