ROTAIO GB0002

GUDID 04047844047873

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: 04047844047873
• NIH Device Record Key: 7a62d109-d935-41b9-a8ce-3baf4937fcba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ROTAIO
• Version Model Number: Positioner
• Catalog Number: GB0002
• 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
• 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
• 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	04047844047873 [Primary]

FDA Product Code

• LXH: Orthopedic Manual Surgical Instrument

Sterilization

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

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

[04047844047873]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-07-01
• Device Publish Date: 2022-06-23

Devices Manufactured by SIGNUS Medizintechnik GmbH

• 04047844130124 - INSTRUMENT: 2026-01-27 An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or
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• 04047844122884 - CYLOX ST 12°: 2025-09-19 The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of int
• 04047844122891 - CYLOX ST 12°: 2025-09-19 The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of int
• 04047844122907 - CYLOX ST 12°: 2025-09-19 The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of int
• 04047844122914 - CYLOX ST 12°: 2025-09-19 The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of int
• 04047844122921 - CYLOX ST 12°: 2025-09-19 The SIGNUS CYLOX® ST Interbody System is an anterior cervical intervertebral body fusion system. Zhe system is comprised of int