Catalog Number

500220

Brand Name

Urocare® "High-Quality" Latex Finger Cots, Medium 20mm (Box of 144)

Version/Model Number

500220

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

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

LZB

Product Code Name

Finger Cot

Public Device Record Key

fc5aa212-a6a4-4e5e-b3fc-cf15acb4263f

Public Version Date

June 29, 2018

Public Version Number

1

DI Record Publish Date

May 29, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-