Catalog Number

-

Brand Name

MediChoice

Version/Model Number

FG2003

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

KDC

Product Code Name

INSTRUMENT, SURGICAL, DISPOSABLE

Public Device Record Key

eee7d01a-6bad-4388-b99b-3bcd883aae94

Public Version Date

October 02, 2020

Public Version Number

1

DI Record Publish Date

September 24, 2020

Package DI Number

50885632110403

Quantity per Package

25

Contains DI Package

10885632110405

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-