11" Guide Wire

GUDID 00850040139570

SURGENTEC, LLC

Orthopaedic prosthesis implantation positioning instrument, single-use

• Primary Device ID: 00850040139570
• NIH Device Record Key: 9c12bb48-668b-4e08-a592-11c18a256e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 11" Guide Wire
• Version Model Number: SR11-5001
• Company DUNS: 004095409
• Company Name: SURGENTEC, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: false
• 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	00850040139570 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211855

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[00850040139570]

Moist Heat or Steam Sterilization

[00850040139570]

Moist Heat or Steam Sterilization

[00850040139570]

Moist Heat or Steam Sterilization

[00850040139570]

Moist Heat or Steam Sterilization

[00850040139570]

Moist Heat or Steam Sterilization

[00850040139570]

Moist Heat or Steam Sterilization

[00850040139570]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-17
• Device Publish Date: 2026-03-09

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