AccessGUDID - DEVICE: Mariner RDX (10889981289942)

GUDID

Device Identifier (DI) Information

Brand Name: Mariner RDX
Version or Model: MX2-000080
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MX2-000080
Company Name: Seaspine Orthopedics Corporation

Primary DI Number: 10889981289942
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 079840876 *Terms of Use

Device Description: Mariner RDX Reducer Extension

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:	No
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?
44804	Orthopaedic rod reducer	A heavy-duty, hand-held manual surgical instrument intended to be used to reduce or seat an implantable rod into the saddle of an implant (i.e., bone screw, spinal hook) used as a component of a system to apply force to a series of vertebrae to correct scoliosis (lateral curvature of the spine) or other spinal conditions. When the rod lies medial or lateral to the implant channel this instrument allows for controlled translation of the rod into the saddle of the screws and/or hooks. The surgeon is able to control the positioning (bending) of the rod into the saddle. Once the rod is securely seated in the saddle it is locked into position with a plug or a setscrew. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQ	Appliance, fixation, spinal intervertebral body
NKB	Thoracolumbosacral pedicle screw system

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K222110	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

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

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: cf93b90f-bfa8-4050-8f3f-bb1e1450e8be
Public Version Date: December 30, 2024
Public Version Number: 2
DI Record Publish Date: January 06, 2023