ResCUBE™

GUDID 03760185576109

The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament

COUSIN BIOTECH

Internal spinal fixation system cable

• Primary Device ID: 03760185576109
• NIH Device Record Key: 22e54d1e-203d-48b3-af08-7fceca691f2f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ResCUBE™
• Version Model Number: RCBCUBETUU
• Company DUNS: 776742439
• Company Name: COUSIN BIOTECH
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com
• Phone: +33320144120
• Email: serviceclients@cousin-surgery.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.
• Special Storage Condition, Specify: Between 0 and 0 *The device must be handled and stored with great care, in a dry place, protected from sunlight and at room temperature in its original packaging.

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760185576109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K181799

FDA Product Code

• OWI: Bone Fixation Cerclage, Sublaminar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-01-15
• Device Publish Date: 2024-01-05

Devices Manufactured by COUSIN BIOTECH

• 03760185576109 - ResCUBE™: 2024-01-15The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the development of solid bony fusion and aid in the repair of bone fractures. It consists of: - A ligament allowing correction and stabilization of the levels, after tensioning - A malleable leader allowing guidance of the ligament during surgery and attached to the ligament by a PET sheath. The lamella and shrink sleeve are not intended for long term implantation and must be removed after placement of the implant. - A low-profile connector holding the tension on the ligament
• 03760185576109 - ResCUBE™: 2024-01-15 The ResCUBE™ System is a temporary spinal implant intended to provide temporary stabilization as a bone anchor during the deve
• 03760185570336 - Biomesh® CA.B.S.’Air® Composite: 2020-10-21 The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug,
• 03760185570343 - Biomesh® CA.B.S.’Air® Composite: 2020-10-21 The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug,
• 03760185570367 - BIOMESH®CA.B.S.'Air®: 2020-10-21 The BIOMESH® CA.B.S.'Air® prosthesis consists of (according to the references on the box): - A parietal prosthesis made of a
• 03760185570374 - Biomesh® CA.B.S.’Air® Composite: 2020-10-21 The BIOMESH® CA.B.S.'Air® Composite prosthesis consists of: - A parietal prosthesis made of an ePTFE and polypropylene plug,
• 03760185570381 - BIOMESH®CA.B.S.'Air®: 2020-10-21 The BIOMESH® CA.B.S.'Air® prosthesis consists of (according to the references on the box): - A parietal prosthesis made of a
• 03760185572323 - 4DDOME ®: 2020-10-21 The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.
• 03760185572347 - 4DDOME ®: 2020-10-21 The device 4DDOME® consists of a dome and semi-resorbable reinforcement mesh for the anterior and posterior reinforcement.