Catalog Number

-

Brand Name

Inspire

Version/Model Number

INSBKNG-M

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

K170393,K170393,K170393

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

8c8d4efe-b709-4588-9555-0d252cfcd500

Public Version Date

August 18, 2022

Public Version Number

1

DI Record Publish Date

August 10, 2022

Package DI Number

10816554013529

Quantity per Package

10

Contains DI Package

00816554013522

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case