AccessGUDID - DEVICE: neuro|mate® - Bone fixation drill 3mm (03662724000161)

GUDID

Device Identifier (DI) Information

Brand Name: neuro|mate® - Bone fixation drill 3mm
Version or Model: Fiducial fixation kit
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 039.0345
Company Name: RENISHAW MAYFIELD

Primary DI Number: 03662724000161
Issuing Agency: GS1
Commercial Distribution End Date: October 19, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 277433335 *Terms of Use

Device Description: The drill is used to create a hole in the patient's skull to screw the temporary implant insert.

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):	No
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?
32568	Neurological stereotactic surgery system	An assembly of devices that typically consists of a rigid frame, positioning and alignment components, workstation, and a calibrated guide mechanism for precisely positioning probes, other instruments, or implantable devices during neurosurgery. The system may include computerized functions to store diagnostic images used for image-guided surgery.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HAW	Neurological Stereotaxic Instrument

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K132755	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: e1fed502-52eb-4f0f-8133-19952118c7ea
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: October 18, 2016