Guidewire - 12"

GUDID 00850040139877

SURGENTEC, LLC

Orthopaedic fixation plate, bioabsorbable

• Primary Device ID: 00850040139877
• NIH Device Record Key: b4d3827d-7566-436a-9043-4359dbe6a550
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Guidewire - 12"
• Version Model Number: SR21-5001
• 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	00850040139877 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230446

FDA Product Code

• OUR: Sacroiliac Joint Fixation

Sterilization

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

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

[00850040139877]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-11-11
• Device Publish Date: 2024-11-01

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