Catalog Number

1127180

Brand Name

Henry Schein

Version/Model Number

1127180

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

HQP

Product Code Name

UNIT, CAUTERY, THERMAL, BATTERY-POWERED

Public Device Record Key

c2b19317-a19e-4116-bb8e-7eaf27ec07ec

Public Version Date

November 01, 2021

Public Version Number

4

DI Record Publish Date

September 24, 2016

Package DI Number

10304040007317

Quantity per Package

10

Contains DI Package

00304040007310

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-