Cannulated Femur Nail, Left 12212-320

GUDID 09120047303306

Cannulated Femur Nail, Left, D=12.0mm, L=320mm

I.T.S. GmbH

Femur intramedullary nail

• Primary Device ID: 09120047303306
• NIH Device Record Key: 041443bd-88fc-45e5-a008-d593c1addf8c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Femur Nail, Left
• Version Model Number: 12212-320
• Catalog Number: 12212-320
• Company DUNS: 303456917
• Company Name: I.T.S. GmbH
• Device Count: 1
• DM Exempt: true
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09120047303306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132945

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

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

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

[09120047303306]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2025-09-04
• Device Publish Date: 2016-09-14

On-Brand Devices [Cannulated Femur Nail, Left]

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• 09120047304532: Cannulated Femur Nail, Left, D=12.0mm, L=400mm
• 09120047304525: Cannulated Femur Nail, Left, D=12.0mm, L=460mm
• 09120047304440: Cannulated Femur Nail, Left, D=10mm, L=420mm
• 09120047304433: Cannulated Femur Nail, Left, D=12.0mm, L=420mm
• 09120047304426: Cannulated Femur Nail, Left, D=12.0mm, L=360mm
• 09120047303405: Cannulated Femur Nail, Left, D=10mm, L=440mm
• 09120047303382: Cannulated Femur Nail, Left, D=10mm, L=400mm
• 09120047303351: Cannulated Femur Nail, Left, D=10mm, L=320mm
• 09120047303337: Cannulated Femur Nail, Left, D=12.0mm, L=380mm
• 09120047303313: Cannulated Femur Nail, Left, D=12.0mm, L=340mm
• 09120047303306: Cannulated Femur Nail, Left, D=12.0mm, L=320mm
• 09120047303276: Cannulated Femur Nail, Left, D=10mm, L=380mm
• 09120047303269: Cannulated Femur Nail, Left, D=10mm, L=360mm
• 09120047303245: Cannulated Femur Nail, Left, D=10mm, L=340mm
• 09120047303238: Cannulated Femur Nail, Left, D=12.0mm, L=440mm
• 09120047302200: Cannulated Femur Nail, Left, D=12.0mm, L=300mm
• 09120047302163: Cannulated Femur Nail, Left, D=10mm, L=300mm