Catalog Number

DC103

Brand Name

Medline

Version/Model Number

DC103

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

f7e85817-c034-4d1e-820f-270e69e7dfc8

Public Version Date

September 30, 2021

Public Version Number

1

DI Record Publish Date

September 22, 2021

Package DI Number

40080196007135

Quantity per Package

1000

Contains DI Package

10080196007134

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE