Catalog Number

-

Brand Name

Exhaust Collection Bag

Version/Model Number

FGS-7005

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

P180032,P180032

Product Code

MNB

Product Code Name

Device, Thermal Ablation, Endometrial

Public Device Record Key

d8b2c460-d55a-4dfd-b004-47bba345dbb1

Public Version Date

August 31, 2020

Public Version Number

1

DI Record Publish Date

August 21, 2020

Package DI Number

20850008595022

Quantity per Package

10

Contains DI Package

00850008595028

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box of 10