DTRAX® Spinal System-L DX-22-600

GUDID 10852776006185

A set of individual non-powered, disposable, hand-held surgical instruments intended and indicated for preparation of a spinal joint to aid in fusion. The set contains trial spacers, an awl, and a screwdriver.

PROVIDENCE MEDICAL TECHNOLOGY, INC.

Internal spinal fixation procedure kit, single-use

• Primary Device ID: 10852776006185
• NIH Device Record Key: f78fb550-ed1f-4522-a5d7-ff1ee90af710
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DTRAX® Spinal System-L
• Version Model Number: DX-22-600
• Catalog Number: DX-22-600
• Company DUNS: 969820245
• Company Name: PROVIDENCE MEDICAL TECHNOLOGY, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: MR Unsafe
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852776006188 [Primary]
GS1	10852776006185 [Package]; Contains: 00852776006188; Package: Box [1 Units]; In Commercial Distribution

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[10852776006185]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-06-07
• Device Publish Date: 2016-10-12

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