Catalog Number

-

Brand Name

BAHADIR USA

Version/Model Number

Y820.12

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K131407

Product Code

FSM

Product Code Name

Tray, Surgical, Instrument

Public Device Record Key

e8d422b6-036f-4bcb-9a1a-eeb3bc2e1ada

Public Version Date

July 08, 2021

Public Version Number

6

DI Record Publish Date

August 14, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-