AccessGUDID - DEVICE: ResCUBE™ (03760185576109)

GUDID

Device Identifier (DI) Information

Brand Name: ResCUBE™
Version or Model: RCBCUBETUU
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: COUSIN BIOTECH

Primary DI Number: 03760185576109
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 776742439 *Terms of Use

Device Description: 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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
44797	Internal spinal fixation system cable	An implantable fixation device designed to apply a force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. The device is typically made of braided medical grade titanium (Ti) and stainless steel alloy of various lengths and designs (e.g., it may be supplied with or without attached fasteners). The cable is tightened with a tension device and is fastened or crimped at each eye-type screw.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
OWI	Bone Fixation Cerclage, Sublaminar

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181799	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: 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.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 22e54d1e-203d-48b3-af08-7fceca691f2f
Public Version Date: January 15, 2024
Public Version Number: 1
DI Record Publish Date: January 05, 2024