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traxi Panniculus Retractor Eval Kit
EUDAMEDFDA UDIClass I (EU MDR)
Ref PRS-EVALModel PRS-0530
Identity
- Trade Name
- traxi Panniculus Retractor Eval Kit EUDAMEDtraxi® Panniculus Retractor FDA UDI
- Generic Name
- Abdominal retractor, hand-held FDA UDI
- Device Name
- traxi Panniculus Retractor EUDAMEDTraxi Panniculus Retractor with Retentus Technology FDA UDI
- Model / Reference
- PRS-0530 EUDAMEDPRS-EVAL EUDAMEDFDA UDI
- Description
- Traxi Panniculus Retractor with Retentus Technology FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247020802 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247001030QV EUDAMED
- FDA Product Code
- CCX FDA UDI
- EMDN Code
- Z12080399 VARIOUS CHILDBIRTH SUPPORT AND MATERNAL ASSISTANCE INSTRUMENTS - OTHER EUDAMED
- GMDN Term
- Abdominal retractor, hand-held FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 868.6820 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
traxi Panniculus Retractor Eval Kit by Clinical Innovations, LLC — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0814247001030QV | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clinical Innovations, LLC
- EUDAMED SRN
- US-MF-000031386
- Authorised Representative
- MVF FR-AR-000011189
Sources (2)
- EUDAMED a57cee76-ef9b-4169-ba02-8cad770167a0 61 fields · synced Jul 11, 2026
- FDA UDI c8e9c1c5-8a85-4ce6-9284-a714a067d4a9 33 fields · synced May 30, 2026