Sectra Orthopedic Package

GUDID 07350092810111

Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative planning and post-operative follow-up. The device has fu

Sectra AB

Radiology picture archiving and communication system workstation

• Primary Device ID: 07350092810111
• NIH Device Record Key: 84a32bb5-0d58-4a1e-b0cd-d20502acaba8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Sectra Orthopedic Package
• Version Model Number: 11.2
• Company DUNS: 354117848
• Company Name: Sectra AB
• 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: false
• Lot Batch: false
• 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

Customer Support Contacts

• Phone: +4613235206
• Email: regulatoryaffairs@sectra.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07350092810111 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K031590

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-12-03
• Device Publish Date: 2018-11-02

On-Brand Devices [Sectra Orthopedic Package]

• 07350092810111: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810081: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810043: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810029: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810227: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810258: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810364: Sectra Orthopaedic Package is intended to assist orthopaedic surgeons when doing preoperative pl
• 07350092810401: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810432: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810463: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810494: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki
• 07350092810555: Sectra Orthopaedic Package is intended to assist the user when doing preoperative planning, maki