Catalog Number

FSC6761

Brand Name

PDC

Version/Model Number

FSC6761

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

KKX

Product Code Name

Drape, Surgical

Public Device Record Key

c24e85a1-9366-419d-bfce-7b0eaa0fa84a

Public Version Date

July 12, 2021

Public Version Number

1

DI Record Publish Date

July 02, 2021

Package DI Number

00850033380002

Quantity per Package

50

Contains DI Package

00850031271999

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE