Catalog Number

C050100

Brand Name

FLUID MANAGEMENT PACK

Version/Model Number

C050100

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

NWW

Product Code Name

Hysteroscope Accessories

Public Device Record Key

3e8ab1d8-0c23-4d8e-80a1-6689aa902fb8

Public Version Date

March 29, 2018

Public Version Number

2

DI Record Publish Date

September 21, 2016

Package DI Number

M648C0501002

Quantity per Package

8

Contains DI Package

M648C0501001

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE