Catalog Number

SG-1

Brand Name

ORI

Version/Model Number

SG-1

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

LYU

Product Code Name

Accessory, Surgical Apparel

Public Device Record Key

eef9e618-573b-4b38-91fd-c2818ef4b6e9

Public Version Date

April 06, 2020

Public Version Number

2

DI Record Publish Date

December 02, 2019

Package DI Number

00850003355931

Quantity per Package

25

Contains DI Package

00850003355924

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case