Catalog Number

-

Brand Name

PACKARD HEALTHCARE ISOLATION GOWN L2 KNIT CUFF

Version/Model Number

6070553450

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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"

-

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

35da067a-63cd-473d-8c3b-ab9d0c96647d

Public Version Date

September 27, 2022

Public Version Number

1

DI Record Publish Date

September 19, 2022

Package DI Number

D89260705534502

Quantity per Package

100

Contains DI Package

D89260705534501

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE