Catalog Number

8035

Brand Name

MEDICOM

Version/Model Number

8035

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

FYF

Product Code Name

CAP, SURGICAL

Public Device Record Key

c9bb925f-f1a7-408f-90af-eebbc4694357

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

January 24, 2019

Package DI Number

20686864047487

Quantity per Package

10

Contains DI Package

10686864047480

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Outer Case