SIFix 03.200.005

GUDID B946032000050

Dilator 5 Assy

NUTECH SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: B946032000050
• NIH Device Record Key: 8330786b-69ff-4541-a147-3d2636aa38b3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SIFix
• Version Model Number: IR
• Catalog Number: 03.200.005
• 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	B946032000050 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

Moist Heat or Steam Sterilization

[B946032000050]

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

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• B946036000010: SIFix Bone Tamp
• B946035040010: Inserter Knob
• B946035030010: SIFix Inserter Inner Shaft
• B946035000010: SIFix Inserter Assy
• B946034000030: SIFix Iliac Wing Reamer
• B946034000020: SIFix Drill Bit 42mm Cannulated
• B946034000010: SIFix Drill Bit 42mm
• B9460330000110: SIFix Drill Guide Assy
• B946033000010: SIFix Drill Guide Assy
• B946032000050: Dilator 5 Assy
• B946032000040: Dilator 4
• B946032000030: Dilator 3
• B946032000020: Dilator 2
• B946032000010: Dilator 1
• B946031100010: SIFix Depth Gauge
• B946031002600: 2.6mm Kwire 317mm-Round Tip
• B946031000020: 2.6mm Kwire 410mm-Round Tip
• B946037000020: SIFix Slap Hammer
• B946007020010: Pin Puller