Catalog Number

10715-01

Brand Name

Tissue Processing Unit

Version/Model Number

10715-01

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

-

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

JQC

Product Code Name

Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Public Device Record Key

ab411e54-fa5e-4fb1-ac3b-6d83da742636

Public Version Date

October 19, 2021

Public Version Number

2

DI Record Publish Date

October 05, 2018

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-