Catalog Number

-

Brand Name

Radial Jaw 4

Version/Model Number

M00513390

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"

-

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

86c5b714-3edb-4080-9bae-6530560f4980

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 24, 2016

Package DI Number

08714729777977

Quantity per Package

20

Contains DI Package

08714729745655

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-