Catalog Number

-

Brand Name

Inspire

Version/Model Number

IHBBH005

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGX

Product Code Name

Tape and bandage, adhesive

Public Device Record Key

58b7d403-dc26-4533-b658-f072f40c3cb8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

November 07, 2016

Package DI Number

05060206921689

Quantity per Package

10

Contains DI Package

05060206921672

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box