Catalog Number

SG1

Brand Name

Rospital Productos Medicos

Version/Model Number

SG1

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

FYF

Product Code Name

Cap, Surgical

Public Device Record Key

98b88294-d756-4603-89b2-e068a3cc7134

Public Version Date

December 22, 2021

Public Version Number

2

DI Record Publish Date

September 29, 2020

Package DI Number

10812460028084

Quantity per Package

100

Contains DI Package

00812460028087

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

INNER CASE