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ABBy™ Postoperative Panniculus Retractor
EUDAMEDFDA UDIClass I (EU MDR)
Ref PRSA-05SM
Identity
- Trade Name
- ABBy™ Postoperative Panniculus Retractor EUDAMEDABBy FDA UDI
- Generic Name
- Panniculus skin-adhesive retractor, reusable FDA UDI
- Device Name
- ABBy™ Postoperative Panniculus Retractor - Small EUDAMEDABBy Panniculus Retractor - 05 Small FDA UDI
- Model / Reference
- PRSA-05SM EUDAMEDFDA UDI
- Description
- ABBy Panniculus Retractor - 05 Small FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247021168 EUDAMEDFDA UDI
- Basic UDI-DI
- 0814247000001QF EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- L03140105 SKIN RETRACTORS, REUSABLE EUDAMED
- GMDN Term
- Panniculus skin-adhesive retractor, reusable FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
Yes
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
ABBy™ Postoperative Panniculus Retractor 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 | 0814247000001QF | 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 ea3e41eb-2a85-4107-a03b-ba6a5a700da5 61 fields · synced Jun 19, 2026
- FDA UDI 4ea7cdac-72d7-44c4-a00a-ec4bb3cb20a9 33 fields · synced May 30, 2026