Catalog Number

18204

Brand Name

Silver D: DV-58

Version/Model Number

18204

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

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)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

IWZ

Product Code Name

Film, Radiographic

Public Device Record Key

b8a3c23c-a5d4-4c1c-8364-ccde29b59388

Public Version Date

January 06, 2020

Public Version Number

3

DI Record Publish Date

August 15, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-