Catalog Number

-

Brand Name

Precept®

Version/Model Number

51198

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

490d2f72-d6bc-4b38-ad14-96214048c0af

Public Version Date

October 19, 2018

Public Version Number

1

DI Record Publish Date

September 18, 2018

Package DI Number

20814707020865

Quantity per Package

10

Contains DI Package

10814707020868

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case