Catalog Number

-

Brand Name

Paneffort

Version/Model Number

SMGL2-FBTN-1X

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

OEA

Product Code Name

Non-Surgical Isolation Gown

Public Device Record Key

d02fe548-f414-482e-ab40-900a4d0e1fb9

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 29, 2022

Package DI Number

20810101310076

Quantity per Package

10

Contains DI Package

10810101310079

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case