Cannulated Tibia Nail 11210-285

GUDID 09120047301395

Cannulated Tibia Nail, D=10mm, L=285mm

I.T.S. GmbH

Tibia intramedullary nail

• Primary Device ID: 09120047301395
• NIH Device Record Key: a0eb139b-4586-4465-9b68-15448ff3859f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cannulated Tibia Nail
• Version Model Number: 11210-285
• Catalog Number: 11210-285
• 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	09120047301395 [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

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

Moist Heat or Steam Sterilization

[09120047301395]

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 Tibia Nail]

• 09120047304471: Cannulated Tibia Nail, D=10mm, L=420mm
• 09120047304464: Cannulated Tibia Nail, D=10mm, L=405mm
• 09120047304457: Cannulated Tibia Nail, D=9.0mm, L=420mm
• 09120047304020: Cannulated Tibia Nail, D=10mm, L=375mm
• 09120047304013: Cannulated Tibia Nail, D=10mm, L=300mm
• 09120047302118: Cannulated Tibia Nail, D=10mm, L=390mm
• 09120047301968: Cannulated Tibia Nail, D=9.0mm, L=315mm
• 09120047301739: Cannulated Tibia Nail, D=10mm, L=345mm
• 09120047301722: Cannulated Tibia Nail, D=10mm, L=330mm
• 09120047301692: Cannulated Tibia Nail, D=10mm, L=315mm
• 09120047301456: Cannulated Tibia Nail, D=9.0mm, L=390mm
• 09120047301449: Cannulated Tibia Nail, D=9.0mm, L=375mm
• 09120047301432: Cannulated Tibia Nail, D=9.0mm, L=360mm
• 09120047301425: Cannulated Tibia Nail, D=9.0mm, L=345mm
• 09120047301418: Cannulated Tibia Nail, D=9.0mm, L=330mm
• 09120047301395: Cannulated Tibia Nail, D=10mm, L=285mm
• 09120047301388: Cannulated Tibia Nail, D=9.0mm, L=405mm
• 09120047301371: Cannulated Tibia Nail, D=9.0mm, L=300mm
• 09120047301364: Cannulated Tibia Nail, D=9.0mm, L=285mm
• 09120047301241: Cannulated Tibia Nail, D=10mm, L=360mm