Identity
- Trade Name
- traxi® Panniculus Retractor Extender FDA UDI
- Generic Name
- Abdominal retractor, hand-held FDA UDI
- Device Name
- Traxi Extender (BMI>50 - used with PH-25) FDA UDI
- Model / Reference
- PRS-1050 FDA UDI
- Description
- Traxi Extender (BMI>50 - used with PH-25) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020369 FDA UDI
- FDA Product Code
- CCX FDA UDI
- GMDN Term
- Abdominal retractor, hand-held FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 868.6820 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: Abdominal retractor, hand-held
traxi® Panniculus Retractor Extender by Clinical Innovations, LLC — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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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 | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
Sources (2)
- FDA UDI 99e85103-bd4a-4425-9dab-a497696fbac5 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 4, 2026