AccessGUDID - DEVICE: Clear Guide VisiMARKER II Non-Sterile (B201CGVM2NS0)

GUDID

Device Identifier (DI) Information

Brand Name: Clear Guide VisiMARKER II Non-Sterile
Version or Model: CGVM2NS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CG-VM2-NS
Company Name: CLEAR GUIDE MEDICAL, INC.

Primary DI Number: B201CGVM2NS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 965399905 *Terms of Use

Device Description: The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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?
47020	Imaging lesion localization marker, external, single-use	A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAC	System, X-Ray, Film Marking, Radiographic

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes 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: 9c067566-c982-473b-b590-e097764b4261
Public Version Date: October 12, 2022
Public Version Number: 1
DI Record Publish Date: October 04, 2022

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
B201CGVM2NS1	15	B201CGVM2NS0	In Commercial Distribution	Shelf Box
B201CGVM2NS3	1	B201CGVM2NS1	In Commercial Distribution	Mailer Box
B201CGVM2NS2	16	B201CGVM2NS1	In Commercial Distribution	Shipper Box