Catalog Number

-

Brand Name

CELLUTOME™

Version/Model Number

CT-H25

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

GFD

Product Code Name

Dermatome

Public Device Record Key

c2735efc-d056-47cd-93c6-6c2ff9ba26b8

Public Version Date

June 22, 2021

Public Version Number

5

DI Record Publish Date

September 24, 2016

Package DI Number

00849554001190

Quantity per Package

5

Contains DI Package

00849554001213

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

5 PACK