Catalog Number

68-6201-B

Brand Name

SURGIPLUS

Version/Model Number

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)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

5ad41a22-6df7-497c-be25-524a53e6d877

Public Version Date

July 28, 2020

Public Version Number

2

DI Record Publish Date

May 15, 2020

Package DI Number

04895237102117

Quantity per Package

1

Contains DI Package

04895237102124

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case