STORM NON STERILE operating kit 1-10-0

GUDID 05060309870297

METAPHYSIS LLP

Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use Orthopaedic surgical procedure kit, non-medicated, single-use

• Primary Device ID: 05060309870297
• NIH Device Record Key: c6f93204-711e-4161-a9b8-f1535bea892c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STORM NON STERILE operating kit
• Version Model Number: 1-10-0
• Catalog Number: 1-10-0
• Company DUNS: 219570490
• Company Name: METAPHYSIS LLP
• 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: true
• 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

Customer Support Contacts

• Phone: +4408458004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com
• Phone: +448448004405
• Email: info@io-uk.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060309870297 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K061607

FDA Product Code

• HWC: Screw, Fixation, Bone

Sterilization

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

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

[05060309870297]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

Devices Manufactured by METAPHYSIS LLP

• 05060309870433 - STORM: 2023-05-12 STORM STERILE OPERATING KIT (1-10-10 wires only) Pack of 5
• 05060309870297 - STORM NON STERILE operating kit: 2018-07-06
• 05060309870297 - STORM NON STERILE operating kit: 2018-07-06
• 5060309870020 - STORM Sterile Operating Kit: 2018-03-29 Sterile Storm Operating Kit
• 05060309872000 - IOS: 2018-03-29 IOS external fixator system (Long)
• 05060309872017 - IOS: 2018-03-29 IOS external fixator system (short)