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Surgical Tools for Erythrocyte and Marrow Preparation Kit
FDA UDIEUDAMEDIdentity
- Trade Name
- Surgical Tools for Erythrocyte and Marrow Preparation Kit FDA UDI
- Generic Name
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
- Device Name
- Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument. FDA UDI
- Model / Reference
- MAR01-O-105 FDA UDI
- Description
- Sterile Disposable Kit containing single-patient-use components necessary for each platelet separation procedure with the MAGELLAN® Autologous Platelet Separator Instrument. FDA UDI
Identifiers
- Primary DI / UDI-DI
- M896MAR01O1050 FDA UDI
- GMDN Term
- Haematological concentrate system preparation kit, platelet concentration FDA UDI
Classification
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Haematological concentrate system preparation kit, platelet concentration
Surgical Tools for Erythrocyte and Marrow Preparation Kit by Arteriocyte Medical Systems, Inc. — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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Also classified as Haematological concentrate system preparation kit, platelet concentration.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | N/A | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | N/A | Pending data |
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Manufacturer
- Manufacturer
- Arteriocyte Medical Systems, Inc.
Sources (2)
- FDA UDI 26ab1af3-d7dc-4853-bc93-3fc37402e346 33 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026