NuTech Spine 00.801.004

GUDID B946008010040

Handle-Teardrop, Cannulated, LG Hudson (Fixed)

NUTECH SPINE, INC.

Surgical instrument handle, non-torque-limiting

• Primary Device ID: B946008010040
• NIH Device Record Key: 44ceb07c-b635-4c45-8bab-c37b350d837d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NuTech Spine
• Version Model Number: IR
• Catalog Number: 00.801.004
• 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: false
• 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	B946008010040 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

[B946008010040]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-02
• Device Publish Date: 2020-09-24

Devices Manufactured by NUTECH SPINE, INC.

• B946011000010 - NuFix: 2024-07-23 1.6mm Kwire 241mm - Trocar Tip
• B946007020010 - SIFix: 2023-11-24 Pin Puller
• B946037000020 - SIFix: 2023-11-24 SIFix Slap Hammer
• B946008010040 - NuTech Spine: 2020-10-02Handle-Teardrop, Cannulated, LG Hudson (Fixed)
• B946008010040 - NuTech Spine: 2020-10-02 Handle-Teardrop, Cannulated, LG Hudson (Fixed)
• B946014000010 - NuFix: 2020-10-02 4.5mm NuFix Drill Bit
• B946021000010 - NuFix II: 2020-10-02 NuFix II Go/No-Go Gage
• B946024000010 - NuFix II: 2020-10-02 NuFix II Drill, 4.5mm
• B946024000030 - NuFix II: 2020-10-02 NuFix II Broach