Clear Guide TipTAG - CLEAR GUIDE MEDICAL, INC.

Duns Number:965399905

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More Product Details

Catalog Number

-

Brand Name

Clear Guide TipTAG

Version/Model Number

CGTT

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

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)

-

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

40bbefbb-6388-4fc4-9a01-2a5614400d52

Public Version Date

October 07, 2022

Public Version Number

3

DI Record Publish Date

April 07, 2017

Additional Identifiers

Package DI Number

B201CGTT1

Quantity per Package

10

Contains DI Package

B201CGTT0

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-

"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