Distal Femur Plate, 21302-5

GUDID 09120034307065

Distal Femur Plate, 5-Hole, Left

I.T.S. GmbH

Orthopaedic fixation plate, non-bioabsorbable

• Primary Device ID: 09120034307065
• NIH Device Record Key: c646769c-fb95-4ce3-8725-628e8960142b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Distal Femur Plate,
• Version Model Number: 21302-5
• Catalog Number: 21302-5
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• 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: 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120034307065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K093868

FDA Product Code

• HRS: Plate, Fixation, Bone

Sterilization

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

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

[09120034307065]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2024-08-07
• Device Publish Date: 2016-09-08

On-Brand Devices [Distal Femur Plate,]

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• 09120047300299: Distal Femur Plate, 7-Hole, Left
• 09120047299821: Distal Femur Plate, 11-Hole, Right
• 09120034307072: Distal Femur Plate, 9-Hole, Left
• 09120034307065: Distal Femur Plate, 5-Hole, Left
• 09120034307058: Distal Femur Plate, 13-Hole, Right
• 09120034307041: Distal Femur Plate, 9-Hole, Right
• 09120034307034: Distal Femur Plate, 5-Hole, Right