Catalog Number

DOF201

Brand Name

Domia Front

Version/Model Number

DOF201

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

MRI safety Status

MR Unsafe

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

FFL

Product Code Name

Dislodger, Stone, Basket, Ureteral, Metal

Public Device Record Key

54508842-7ed8-4797-b1b1-4c0da06bee88

Public Version Date

August 02, 2021

Public Version Number

1

DI Record Publish Date

July 23, 2021

Package DI Number

B937DOF2011

Quantity per Package

1

Contains DI Package

B937DOF2010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton box