Catalog Number

-

Brand Name

Albahealth

Version/Model Number

CS5512009990304

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K792357,K792357

Product Code

KKX

Product Code Name

Drape, surgical

Public Device Record Key

9afdd1e9-c2a2-42d8-98a6-053dc76a4e13

Public Version Date

December 22, 2021

Public Version Number

6

DI Record Publish Date

September 22, 2016

Package DI Number

50073614767459

Quantity per Package

10

Contains DI Package

00073614767454

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-