Catalog Number

-

Brand Name

ANGELINE

Version/Model Number

RIGL2

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

July 26, 2023

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

-

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

c3c4a973-30f5-436a-8657-2af3d385c342

Public Version Date

August 20, 2020

Public Version Number

1

DI Record Publish Date

August 12, 2020

Package DI Number

14719880260048

Quantity per Package

60

Contains DI Package

04719880260034

Package Discontinue Date

July 23, 2023

Package Status

In Commercial Distribution

Package Type

CASE