Catalog Number

397021

Brand Name

HYDROSET

Version/Model Number

397021

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"

-

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

GEA

Product Code Name

CANNULA, SURGICAL, GENERAL & PLASTIC SURGERY

Public Device Record Key

62447c82-8a0d-4834-9b4b-5313f5f375c5

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

September 24, 2015

Package DI Number

37613154804772

Quantity per Package

10

Contains DI Package

07613154804771

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

pack