Catalog Number

232109

Brand Name

NA

Version/Model Number

232109

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

GDX

Product Code Name

SCALPEL, ONE-PIECE

Public Device Record Key

38ad088a-8a60-4bad-87d2-698dc1597af8

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

September 01, 2015

Package DI Number

20886705010988

Quantity per Package

10

Contains DI Package

10886705010981

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

PACKAGE