Catalog Number

ESTBN18100E

Brand Name

Eclipse PRP, Tropocells

Version/Model Number

ESTBN18100E

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 18, 2016

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

-

Product Code Name

-

Public Device Record Key

75386099-3a98-4919-b17b-12ae5bcdc233

Public Version Date

July 23, 2020

Public Version Number

5

DI Record Publish Date

October 18, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-