Catalog Number

2204053-W

Brand Name

LHB Industries

Version/Model Number

Wide Band Large w/ wipe

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KOA

Product Code Name

Surgical Instruments, G-U, Manual (And Accessories)

Public Device Record Key

3466144c-2da1-4bd7-afb1-14c5b8b5e0b3

Public Version Date

June 10, 2022

Public Version Number

2

DI Record Publish Date

October 01, 2021

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-