CellFUSE™ - CellFUSE™ Granules 5cc - REGENACELL THERAPY INC

Duns Number:018987812

Device Description: CellFUSE™ Granules 5cc

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More Product Details

Catalog Number

CF-G5

Brand Name

CellFUSE™

Version/Model Number

CF-G5

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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 Details

Product Code

MQV

Product Code Name

Filler, Bone Void, Calcium Compound

Device Record Status

Public Device Record Key

e72bca01-04aa-4826-b736-44d54d7f7c7a

Public Version Date

April 15, 2019

Public Version Number

1

DI Record Publish Date

April 05, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"REGENACELL THERAPY INC" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 11