Surgical tools for erythrocyte & marrow preparation kit - Sterile Disposable Kit containing - ARTERIOCYTE MEDICAL SYSTEMS, INC.

Duns Number:809012870

Device Description: Sterile Disposable Kit containing single-patient-use components necessary for each platele Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

MAR02-O-80

Brand Name

Surgical tools for erythrocyte & marrow preparation kit

Version/Model Number

MAR02-O-80

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

October 31, 2022

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

MR Unsafe

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"

Yes

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 Details

Product Code

-

Product Code Name

-

Device Record Status

Public Device Record Key

28bc9590-55e4-43dc-9d47-76e836d0d7c4

Public Version Date

November 01, 2022

Public Version Number

5

DI Record Publish Date

September 09, 2016

Additional Identifiers

Package DI Number

M896MAR02O801

Quantity per Package

1

Contains DI Package

M896MAR02O800

Package Discontinue Date

October 31, 2022

Package Status

Not in Commercial Distribution

Package Type

Box

"ARTERIOCYTE MEDICAL SYSTEMS, INC." Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 6
2 A medical device with a moderate to high risk that requires special controls. 16