Catalog Number

-

Brand Name

Intercept Free

Version/Model Number

1LICFNG-XL

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K220375,K220375,K220375

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

c26e3b48-9c76-46d1-a2de-0cae61e9ee6a

Public Version Date

May 31, 2022

Public Version Number

1

DI Record Publish Date

May 23, 2022

Package DI Number

00150020014508

Quantity per Package

1200

Contains DI Package

00850020014507

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX