250mm Carbon Fiber Rod

GUDID 00810028397095

Medshape, Inc.

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 00810028397095
• NIH Device Record Key: c1fd4659-2efb-4621-bf25-c1e566b60d19
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 250mm Carbon Fiber Rod
• Version Model Number: DNE-9000-250-CF
• Company DUNS: 601306413
• Company Name: Medshape, Inc.
• 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: 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
GS1	00810028397095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K113106

FDA Product Code

• KTT: Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component

Sterilization

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

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[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

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[00810028397095]

Moist Heat or Steam Sterilization

[00810028397095]

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Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-06-10
• Device Publish Date: 2024-05-31

On-Brand Devices [250mm Carbon Fiber Rod]

• 00810028397095: DNE-9000-250-CF
• 00810028396333: DNE-9000-250-CF