Catalog Number

-

Brand Name

Inspire

Version/Model Number

INSSVGPF-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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYZ

Product Code Name

Vinyl patient examination glove

Public Device Record Key

1ac8ce7f-6e58-4e1c-849b-2efe65098e2d

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Package DI Number

10816554010276

Quantity per Package

10

Contains DI Package

00816554010279

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case