Neo Pedicle Screw Kit

GUDID 07640177820518

Pedicle screw kit 2x(Ø4.5 x 25mm)

Neo Medical SA

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• Primary Device ID: 07640177820518
• NIH Device Record Key: 9287e634-46ee-4e7d-b0f0-103c253212a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Neo Pedicle Screw Kit
• Version Model Number: SC-45-25-PE
• Company DUNS: 486778843
• Company Name: Neo Medical SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter
• Outer Diameter: 4.5 Millimeter
• Length: 25 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 5 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	07640177820518 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212489

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-06
• Device Publish Date: 2021-11-26

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