FDA.reportPublic FDA data

Autologous Platelet Separator

Primary DI
M896MAG1001
Brand
Autologous Platelet Separator
Company
ARTERIOCYTE MEDICAL SYSTEMS, INC.
Model
MAG100
Catalog number
MAG100
Device description
MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits.
Published
2016-09-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical UseClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M896MAG1001PackageHIBCC1In Commercial Distribution
M896MAG1000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Haematological concentrate system centrifugeAn electrically-powered device typically intended to be used at the point-of-care to concentrate platelets or bone marrow aspirate cells from a small volume of autologous (patient's own) blood/bone marrow using centrifugal force, for the rapid preparation of platelet-rich plasma (PRP) or bone marrow aspirate concentrate (BMAC). The concentrates are applied to general and orthopaedic surgical sites, or pre-mixed with graft material, to assist the healing and/or graft acceptance process. It includes a rotor head with a receptacle(s) for dedicated autologous specimen processing equipment. This device may additionally have refrigeration capabilities to perform temperature-sensitive procedures.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
866-660-2674customerservice@arteriocyte.com

Regulatory Flags#

DUNS number
809012870
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M896AMS1000Magellan Autologous Platelet Separator SystemAMS100AMS1002016-09-09
M896AMS3000Magellan Complete Disposable KitAMS300AMS3002016-09-12
M896AMS3050Magellan Basic disposable kitAMS305AMS3052016-09-12
M896AMS3100Magellan Complete One Source KitAMS310AMS3102016-09-12
M896BTI2000Magellan Autologous Platelet Separator SystemBTI200BTI2002016-09-09
M896CLPTPK1010CP Disposable KitCLPT-PK-101CLPT-PK-1012018-12-12
M896CLPTPK101450Cellpoint CP Disposable Kit with 45mm Lightning NeedleCLPT-PK-101-45CLPT-PK-101-452020-02-26
M896IBIA55600Small Anchor Awl 5mmIB-IA-5560IB-IA-55602022-12-19
M896IBIA65700Medium Anchor Awl 6mmIB-IA-6570IB-IA-65702022-12-19
M896IBIA75800Large Anchor Awl 7mmIB-IA-7580IB-IA-75802022-12-19
M896IBIA85900Xlarge Anchor Awl 8mmIB-IA-8590IB-IA-85902022-12-19
M896IBK00010Fibrant Instrument Kit IB-K-0001IB-K-00012022-12-19
M896IQSPMX1500InQu Matrix 5x10cmIQSP-MX-150IQSP-MX-1502022-06-23
M896IQSPPP1010InQu Paste Mix Plus 1.25ccIQSP-PP-101IQSP-PP-1012018-08-01
M896IQSPPP1020InQu Paste Mix Plus 2.5ccIQSP-PP-102IQSP-PP-1022018-08-01
M896IQSPPP1050InQu Paste Mix Plus 5ccIQSP-PP-105IQSP-PP-1052018-08-01
M896IQSPPP1100InQu Paste Mix Plus 10ccIQSP-PP-110IQSP-PP-1102018-08-01
M896MAG1000Magellan Autologous Platelet Separator SystemMAG100MAG1002016-09-09
M896MAG2000Magellan Autologous Platelet Separator SystemMAG200MAG2002016-09-09
M896MAR0MAX450Magellan MAR0Max QuickDraw Convenience KitMAR0Max45MAR0Max452016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850044310514Thermo ScientificThermo Electron LED GmbHJQC2026-06-10
10850044310538Thermo ScientificThermo Electron LED GmbHJQC2026-06-10
10850044310545Thermo ScientificThermo Electron LED GmbHJQC2026-06-10
10850044310552Thermo ScientificThermo Electron LED GmbHJQC2026-06-10
00199874104928Life PRP LLCLife PRP, LLCJQC2026-05-30
10850044310262Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310279Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
10850044310309Thermo ScientificThermo Electron LED GmbHJQC2026-05-21
00810052864990Boost 2 Flex DC Centrifuge, RevanceDRUCKER DIAGNOSTICSJQC2026-05-11
00810052865003Boost 4 Centrifuge, Pointiva MedicalDRUCKER DIAGNOSTICSJQC2026-05-11
00810052864983DASH Pro 24 Centrifuge, DruckerDRUCKER DIAGNOSTICSJQC2026-05-04
00810052864976TrueBond TriFLEX Centrifuge, PivetalDRUCKER DIAGNOSTICSJQC2026-04-29
10850044310323Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310347Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310354Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310422Fisher ScientificThermo Electron LED GmbHJQC2026-04-22
10850044310224Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
10850044310248Thermo ScientificThermo Electron LED GmbHJQC2026-04-02
00860015460660Nextgen CentrifugeT AESTHETICS LLCJQC2026-04-02
00810052863016DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00810052864969DASH Flex 24 Centrifuge, Royal BiologicsDRUCKER DIAGNOSTICSJQC2026-03-25
00840095681674Globe ScientificGLOBE SCIENTIFIC INC.JQC2026-03-16
10850044310255Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310286Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310293Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310378Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310392Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310484Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
10850044310491Thermo ScientificThermo Electron LED GmbHJQC2026-03-10
00664816006030LW Scientific, Inc`LW SCIENTIFIC, INC.JQC2026-03-02