AccessGUDID - DEVICE: REgistration Matrix CT Small Incision Spine (04056481140076)

GUDID

Device Identifier (DI) Information

Brand Name: REgistration Matrix CT Small Incision Spine
Version or Model: 55749-02
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 55749-02
Company Name: Brainlab SE

Primary DI Number: 04056481140076
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 314482980 *Terms of Use

Device Description: No description.

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?
47436	Surgical optical-tracking spatial marker holder	A component of a surgical navigation and/or device tracking system (e.g., computer-assisted neurosurgical ultrasound navigation system, surgical microscope with tracking camera) intended to be used preoperatively and/or intraoperatively as a localizer/holder for optical spatial markers (e.g., reflective marker spheres) that are attached to it prior to use. It can be attached to the distal end of an ultrasound transducer (US probe), neurosurgical instrument, hand-held pointer manipulated by the surgeon, or a patient reference point (e.g., head clamp), and is used as part of the tracking system to provide the correct position of the surgical devices and patient. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological Stereotaxic Instrument
OLO	Orthopedic Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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: 66270727-1aec-4edb-8e19-e530618d66c3
Public Version Date: October 27, 2025
Public Version Number: 7
DI Record Publish Date: December 13, 2017