Identity
- Trade Name
- PEAK® Platelet Rich Plasma System FDA UDI
- Generic Name
- Haematological concentrate system centrifuge FDA UDI
- Device Name
- Centrifuge for preparation of platelet rich plasma FDA UDI
- Model / Reference
- 64002-01 FDA UDI
- Description
- Centrifuge for preparation of platelet rich plasma FDA UDI
Identifiers
- Catalog Number
- 278010 FDA UDI
- Primary DI / UDI-DI
- 00812337026215 FDA UDI
- FDA Product Code
- ORG FDA UDI
- GMDN Term
- Haematological concentrate system centrifuge FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.9245 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
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Haematological concentrate system centrifuge
PEAK® Platelet Rich Plasma System by Dsm Biomedical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Haematological concentrate system centrifuge.
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- Autologous Platelet Separator — Arteriocyte Medical Systems, Inc. · Class I
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- Autologous Platelet Separator — Arteriocyte Medical Systems, Inc. · Class I
- LT Medical Centrifuge for PRP — Zhuhai Longtime Biological Technology Co., Ltd · Class I
- 3CP™ Centrifuge — Reapplix ApS · Class I
- LT Medical Centrifuge for PRP — Zhuhai Longtime Biological Technology Co., Ltd · Class I
- DSM Biomedical Centrifuge — DSM BIOMEDICAL, INC. · Class II
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 II | Pending data |
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Manufacturer
- Manufacturer
- Dsm Biomedical, Inc.
Sources (1)
- FDA UDI 84924fad-f514-4e49-8c5a-53398afb5e15 34 fields · synced May 31, 2026