Catalog Number

-

Brand Name

SUMMIT MEDICAL

Version/Model Number

20-HM-2000

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

-

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

HQP

Product Code Name

Unit, Cautery, Thermal, Battery-Powered

Public Device Record Key

884a2258-fa16-45d4-82d2-0ef81e3a5e6a

Public Version Date

August 23, 2021

Public Version Number

2

DI Record Publish Date

April 15, 2021

Package DI Number

10385640053706

Quantity per Package

10

Contains DI Package

00385640053709

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

BOX