Catalog Number

707001

Brand Name

HYDROSET

Version/Model Number

707001

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 2022

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

9cc84ff9-5a60-42b2-b04e-af73a660edf5

Public Version Date

October 19, 2022

Public Version Number

4

DI Record Publish Date

September 24, 2015

Package DI Number

37613154804789

Quantity per Package

10

Contains DI Package

07613154804788

Package Discontinue Date

October 18, 2022

Package Status

Not in Commercial Distribution

Package Type

pack