Catalog Number

SBP15

Brand Name

Rospital Productos Medicos

Version/Model Number

SBP15

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GES

Product Code Name

Blade, Scalpel

Public Device Record Key

2e89f9dd-1ce3-4e51-a879-8664a296b4af

Public Version Date

January 22, 2021

Public Version Number

3

DI Record Publish Date

June 13, 2020

Package DI Number

10812460028053

Quantity per Package

10

Contains DI Package

00812460028056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER