Catalog Number

-

Brand Name

Precisil Monophase

Version/Model Number

Precisil Monophase (50ml * 50 Cartridges)

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)

-

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

4346ce5e-d3d0-4fb8-9cb3-e03569ca5fb2

Public Version Date

October 09, 2019

Public Version Number

1

DI Record Publish Date

October 01, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-