DIANA SH0042

GUDID 04047844059715

An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.

SIGNUS Medizintechnik GmbH

Orthopaedic surgical procedure kit, non-medicated, reusable

• Primary Device ID: 04047844059715
• NIH Device Record Key: 83bd3da4-645b-4ab8-a6a9-82104cf33227
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIANA
• Version Model Number: Reamer
• Catalog Number: SH0042
• Company DUNS: 344203948
• Company Name: SIGNUS Medizintechnik GmbH
• Device Count: 1
• DM Exempt: false
• 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: false
• 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: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com
• Phone: +49602391660
• Email: info@signus.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	04047844059715 [Primary]

FDA Product Code

• LYS: Bone Mill

Sterilization

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

[04047844059715]

Moist Heat or Steam Sterilization

[04047844059715]

Moist Heat or Steam Sterilization

[04047844059715]

Moist Heat or Steam Sterilization

[04047844059715]

Moist Heat or Steam Sterilization

[04047844059715]

Moist Heat or Steam Sterilization

[04047844059715]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-10
• Device Publish Date: 2022-06-02

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• 04047844008393: The DIANA Fusion Cage is comprised of a variety of implant sizes to accomodate various patient a
• 04047844059715: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
• 04047844059685: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p
• 04047844055885: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical p