Catalog Number

-

Brand Name

Clear-Bite Biopsy Forceps

Version/Model Number

FM-EF0003(Coated)(Round)

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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"

Yes

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

FCL

Product Code Name

Forceps, Biopsy, Non-Electric

Public Device Record Key

9a214501-e4ce-4dbe-b5ae-306164e3655c

Public Version Date

April 22, 2019

Public Version Number

1

DI Record Publish Date

April 12, 2019

Package DI Number

18809327352613

Quantity per Package

20

Contains DI Package

08809327352616

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box