Catalog Number

ECO158005

Brand Name

Sureglide

Version/Model Number

ECO158005

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

MR Unsafe

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

dea41850-945d-44e3-86d7-53279ab14f81

Public Version Date

February 06, 2020

Public Version Number

3

DI Record Publish Date

September 21, 2017

Package DI Number

10855009006099

Quantity per Package

10

Contains DI Package

00855009006092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner Pack