Catalog Number

N88TT23L

Brand Name

FLEXAL

Version/Model Number

N88TT23L

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

December 31, 2021

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

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

d2b17598-b0f1-4d7a-bf6f-a690f2cc7e18

Public Version Date

December 31, 2021

Public Version Number

4

DI Record Publish Date

March 14, 2019

Package DI Number

50885380135031

Quantity per Package

20

Contains DI Package

00885380135036

Package Discontinue Date

December 31, 2021

Package Status

Not in Commercial Distribution

Package Type

CASE