Clear Guide VisiMARKER II - The device is a sterile or sterilizable (via - CLEAR GUIDE MEDICAL, INC.

Duns Number:965399905

Device Description: The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intend 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.

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More Product Details

Catalog Number

CG-VM2

Brand Name

Clear Guide VisiMARKER II

Version/Model Number

CGVM2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Safe

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

JAC

Product Code Name

System, X-Ray, Film Marking, Radiographic

Device Record Status

Public Device Record Key

0e30e459-00d7-40b3-80fa-19bc41b33433

Public Version Date

October 12, 2022

Public Version Number

1

DI Record Publish Date

October 04, 2022

Additional Identifiers

Package DI Number

B201CGVM21

Quantity per Package

15

Contains DI Package

B201CGVM20

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Shelf Box

"CLEAR GUIDE MEDICAL, INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 4