Catalog Number

104-9014

Brand Name

SCOTT'S VPS HP REG-SET MONOPHASE 4/bx

Version/Model Number

104-9014

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"

-

For Single-Use

-

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

ELW

Product Code Name

Material, Impression

Public Device Record Key

20aa21ca-70d5-416b-af94-55866f466e37

Public Version Date

August 26, 2020

Public Version Number

3

DI Record Publish Date

February 13, 2017

Package DI Number

D77810490141

Quantity per Package

4

Contains DI Package

D77810490140

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

KIT