Catalog Number

0475-361-001

Brand Name

CrossBlade

Version/Model Number

0475361001

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

GFA

Product Code Name

BLADE, SAW, GENERAL & PLASTIC SURGERY, SURGICAL

Public Device Record Key

d3aa48ef-b243-44c7-a549-b4650b1fc61e

Public Version Date

July 04, 2022

Public Version Number

2

DI Record Publish Date

June 21, 2021

Package DI Number

37613327512343

Quantity per Package

5

Contains DI Package

07613327512342

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack