AccessGUDID - DEVICE: Ruthless Spine RJB

GUDID

Device Identifier (DI) Information

Brand Name: Ruthless Spine RJB - Case
Version or Model: RJB6-Case
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Ruthless Spine

Primary DI Number: G492RJB61
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117227055 *Terms of Use

Device Description: RJB Device (case)

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?
44054	Orthopaedic surgical procedure kit, non-medicated, reusable	A collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
QWL	Intraoperative Surgical Angle Measurement Tool

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN230012	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 31ea4d4c-bf83-47fe-a60c-4fcb3f59a073
Public Version Date: February 06, 2024
Public Version Number: 1
DI Record Publish Date: January 29, 2024