AccessGUDID - DEVICE: Magellan Surgical Tools for Erythrocyte & Marrow Preparation Kit (M896MAR01ATS0)

GUDID

Device Identifier (DI) Information

Brand Name: Magellan Surgical Tools for Erythrocyte & Marrow Preparation Kit
Version or Model: MAR01-ATS
Commercial Distribution Status: In Commercial Distribution
Catalog Number: MAR01-ATS
Company Name: Arteriocyte Medical Systems, Inc.

Primary DI Number: M896MAR01ATS0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 809012870 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47153	Haematological concentrate system preparation kit, bone marrow concentration	A collection of sterile devices typically used at the point-of-care for the rapid preparation of autologous bone marrow aspirate concentrate (BMAC) from bone marrow aspirate. The kit components, with the bone marrow aspirate, are directly placed in a dedicated centrifuge that separates and concentrates the bone marrow. The cellular BMAC preparations are typically applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. The kit may include specimen drawing devices. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JQC	Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15.5 and 40 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: fc9cfc68-898b-4b49-9b95-f1ba593d2ea1
Public Version Date: May 22, 2026
Public Version Number: 6
DI Record Publish Date: May 29, 2017