Catalog Number

43021S9701

Brand Name

RECEPTAL™ 2000 ML LINER WITH SOLIDIFIER

Version/Model Number

1

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

GCX

Product Code Name

Apparatus, Suction, Operating-Room, Wall Vacuum Powered

Public Device Record Key

2ebd9b12-2b68-494e-a2dc-2c66f77647a6

Public Version Date

May 17, 2018

Public Version Number

1

DI Record Publish Date

April 16, 2018

Package DI Number

40704411007730

Quantity per Package

5

Contains DI Package

20704411007736

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case