Catalog Number

-

Brand Name

Alasta® Shimmer Pink®

Version/Model Number

PNK100L

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

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

78d52df5-4f2c-4dc3-b168-7c11b26dec61

Public Version Date

March 17, 2022

Public Version Number

2

DI Record Publish Date

May 31, 2021

Package DI Number

00649531693161

Quantity per Package

10

Contains DI Package

00649531692164

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case