AccessGUDID - DEVICE: ClearPoint (00850376007277)

GUDID

Device Identifier (DI) Information

Brand Name: ClearPoint
Version or Model: CP-MPHFF-212-01
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: CP-MPHFF-212-01
Company Name: Clearpoint Neuro, Inc.

Primary DI Number: 00850376007277
Issuing Agency: GS1
Commercial Distribution End Date: March 19, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 119078557 *Terms of Use

Device Description: ClearPoint Multi-Positional HF/Table Mounts for IMRIS with ORT 100 Table

Device Characteristics

What MRI safety information does the labeling contain?	MR Conditional
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?
35361	Stereotactic radiosurgical invasive head frame	A device intended to be affixed to a patient's skull to enable precise localization of an area within the brain targeted for radiosurgical procedures (e.g., radiation treatment of a brain tumour). It is typically an assembly that includes a head ring or a head frame that is attached to the patient's head with fixation screws partially-embedded into the skull, an arc mechanism for setting target coordinates, and localizer frames and adaptors for precision placement to the simulator and imaging system [e.g., computed tomography (CT), magnetic resonance imaging (MRI), linear accelerator]. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
HBL	Holder, Head, Neurosurgical (Skull Clamp)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K091439	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
Storage Environment Temperature: between 40 and 90 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8050f22c-dd0a-4ff5-8311-a5170cc2d41f
Public Version Date: March 20, 2024
Public Version Number: 5
DI Record Publish Date: January 22, 2021