Catalog Number

-

Brand Name

IMEDICOM Saw Blade

Version/Model Number

XTB510NS

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

GFA

Product Code Name

Blade, Saw, General & Plastic Surgery, Surgical

Public Device Record Key

10961e39-4080-4544-b372-b56c68985711

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

August 03, 2018

Package DI Number

08800038028548

Quantity per Package

10

Contains DI Package

08800038027466

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-