Catalog Number

2235-N

Brand Name

SANDEL

Version/Model Number

2235-N

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"

Yes

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

Yes

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

2c9cb2c8-1c92-4d7f-b4d7-461557a9b1a5

Public Version Date

April 05, 2022

Public Version Number

1

DI Record Publish Date

March 28, 2022

Package DI Number

35414566810137

Quantity per Package

8

Contains DI Package

25414566810130

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case