Identity
- Trade Name
- SPS-1® (UW Solution) FDA UDI
- Generic Name
- Donor-organ/tissue/cell preservation solution FDA UDI
- Device Name
- SPS-1® (UW Solution), Static Preservation Solution (500mL) FDA UDI
- Model / Reference
- SPS-1 FDA UDI
- Description
- SPS-1® (UW Solution), Static Preservation Solution (500mL) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815045020285 FDA UDI
- 510(k) Number
- K091656 FDA UDI
- FDA Product Code
- KDL FDA UDI
- GMDN Term
- Donor-organ/tissue/cell preservation solution FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.5880 FDA UDI
- Commercial Distribution
- Not 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
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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
SPS-1® (UW Solution) by Organ Recovery Systems, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K091656 also covers:
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
- Organ Recovery Systems, Inc.
Sources (1)
- FDA UDI 122d095f-047c-41e1-99e7-a123e79949cc 36 fields · synced Jun 9, 2026