Surgical Tools for Erythrocyte and 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.

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More Product Details

Catalog Number

MAR01-O-25

Brand Name

Surgical Tools for Erythrocyte and Marrow Preparation Kit

Version/Model Number

MAR01-O-25

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

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

a6ab9d9e-3732-445e-840b-0a45f1b0e1e6

Public Version Date

December 22, 2020

Public Version Number

1

DI Record Publish Date

December 14, 2020

Additional Identifiers

Package DI Number

M896MAR01O2501

Quantity per Package

1

Contains DI Package

M896MAR01O250

Package Discontinue Date

-

Package Status

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