Identity
- Trade Name
- Perfusion Clamp with Adaptor FDA UDI
- Generic Name
- Kidney donor-organ preservation/transport perfusion set FDA UDI
- Device Name
- The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device. FDA UDI
- Model / Reference
- PC1025A FDA UDI
- Description
- The Perfusion Clamp is used for explanted organ recovered with aortic patch. It is a sterile, disposable and single-use device. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 13700911900942 FDA UDI
- FDA Product Code
- FKK FDA UDI
- GMDN Term
- Kidney donor-organ preservation/transport perfusion set FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Kidney donor-organ preservation/transport perfusion set
Perfusion Clamp with Adaptor by Institut Georges Lopez — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Institut Georges Lopez
Sources (1)
- FDA UDI 863a7597-991e-4829-89b3-652d5e84ea6e 33 fields · synced May 30, 2026