Catalog Number

800-023

Brand Name

SPECTRUM

Version/Model Number

WIRE CUTTER

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

ECP

Product Code Name

Instrument, Ligature Tucking, Orthodontic

Public Device Record Key

e85c8c44-4a70-4703-a6cb-351f90aab867

Public Version Date

September 26, 2022

Public Version Number

1

DI Record Publish Date

September 17, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-