NuFix 01.100.001

GUDID B946011000010

1.6mm Kwire 241mm - Trocar Tip

Nutech Spine, Inc.

Spinal guidewire

• Primary Device ID: B946011000010
• NIH Device Record Key: 2c015a37-b212-458d-bbd5-c9bca30cbafe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuFix
• Version Model Number: 04
• Catalog Number: 01.100.001
• Company DUNS: 080867996
• Company Name: Nutech Spine, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: false
• Expiration Date: false
• 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
HIBCC	B946011000010 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

[B946011000010]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-23
• Device Publish Date: 2024-07-15

On-Brand Devices [NuFix]

• B946NF10090: Guide Pins
• B946NF10070: 5.0mm Drill Bit
• B946NF10060: Carbon Fiber Handle
• B946NF10050: NuFix Inserter
• B946NF10040: Facet Sound
• B946NF1003C0: 4.5mm Drill Bit - Cannulated
• B946NF10030: 4.5mm NuFix Drill Bit
• B946NF1002T0: Drill Tube
• B946NF10020: Drill Guide
• B946NF1001SC0: Stainless Steel Facet Locator - Cannulated
• B946NF1001S0: Stainless Steel Facet Locator
• B946NF10010: Carbon Fiber Facet Locator
• B946014000010: 4.5mm NuFix Drill Bit
• B946011000010: 1.6mm Kwire 241mm - Trocar Tip