Identity
- Trade Name
- Autologous Platelet Separator FDA UDI
- Generic Name
- Haematological concentrate system centrifuge FDA UDI
- Device Name
- MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits. FDA UDI
- Model / Reference
- AMS100 FDA UDI
- Description
- MAGELLAN® Autologous Platelet Separator System consists of the Platelet Separator Instrument and the associated Platelet Rich Plasma Sterile Disposable Kits. FDA UDI
Identifiers
- Catalog Number
- AMS100 FDA UDI
- Primary DI / UDI-DI
- M896AMS1000 FDA UDI
- FDA Product Code
- JQC FDA UDI
- GMDN Term
- Haematological concentrate system centrifuge FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 862.2050 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Haematological concentrate system centrifuge
Autologous Platelet Separator by Arteriocyte Medical Systems, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological concentrate system centrifuge.
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- 3CP™ Centrifuge — Reapplix ApS · Class I
- LT Medical Centrifuge for PRP — Zhuhai Longtime Biological Technology Co., Ltd · Class I
- PEAK® Platelet Rich Plasma System — DSM BIOMEDICAL, INC. · Class II
- Autologous Platelet Separator — Arteriocyte Medical Systems, Inc. · Class I
- Autologous Platelet Separator — Arteriocyte Medical Systems, Inc. · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Arteriocyte Medical Systems, Inc.
Sources (1)
- FDA UDI 6ac7e9a2-a877-4f18-af56-02e932c5a969 35 fields · synced May 30, 2026