Catalog Number

398972A

Brand Name

Recovery Room Drape Pack

Version/Model Number

398972A

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"

-

For Single-Use

Yes

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

0bef1767-7d46-48ef-bfe2-fbcd8290983a

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 15, 2016

Package DI Number

20886333212792

Quantity per Package

10

Contains DI Package

00886333212798

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box