AccessGUDID - DEVICE: Fluoro Reg Kit Ziehm Vision Fd 20X20 (04056481005276)

GUDID

Device Identifier (DI) Information

Brand Name: Fluoro Reg Kit Ziehm Vision Fd 20X20
Version or Model: 55730
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 55730
Company Name: Brainlab AG

Primary DI Number: 04056481005276
Issuing Agency: GS1
Commercial Distribution End Date: December 15, 2022
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?
38723	Robotic surgical navigation system	An assembly of electromechanical devices used during orthopaedic computer assisted surgery (CAS) as a functional extension of the surgeon for precise procedural movement and placement (navigation) during the procedure (e.g., placement of a pedicle screw in spinal surgery). It is computer-based and typically consists of, e.g., an operator's console and a video camera used to track the instrumentation. The input to the computer is usually by means of an existing CT or MRI scan that is used as a template. The system tracks the instrumentation by reading the location points giving a three-dimensional (3-D) picture of the instrument's position/angulation. It can also be used as a training aid.	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 [?]
K070106	000
K183605	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
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: c917bb15-9cbc-4030-a7ac-4e56ccb99d54
Public Version Date: January 31, 2023
Public Version Number: 6
DI Record Publish Date: September 15, 2016