Catalog Number

33470-4

Brand Name

AMBITEX

Version/Model Number

33470-4

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

K113193,K113193

Product Code

LYZ

Product Code Name

Vinyl patient examination glove

Public Device Record Key

cfb394df-5084-4550-80e2-d58a1140dbed

Public Version Date

March 22, 2021

Public Version Number

2

DI Record Publish Date

June 25, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-