Catalog Number

599N

Brand Name

CONVERTORS

Version/Model Number

599N

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)

-

Over the Counter (OTC)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYU

Product Code Name

ACCESSORY, SURGICAL APPAREL

Public Device Record Key

b25f9397-a7f5-4b0a-9687-2371b9a06a4a

Public Version Date

June 17, 2019

Public Version Number

1

DI Record Publish Date

June 07, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-