Identity
- Trade Name
- ABBy FDA UDI
- Generic Name
- Panniculus skin-adhesive retractor, reusable FDA UDI
- Device Name
- ABBy Panniculus Retractor - 10 Regular FDA UDI
- Model / Reference
- PRSA-10RG FDA UDI
- Description
- ABBy Panniculus Retractor - 10 Regular FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814247021144 FDA UDI
- FDA Product Code
- KGX FDA UDI
- GMDN Term
- Panniculus skin-adhesive retractor, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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: Panniculus skin-adhesive retractor, reusable
ABBy by Clinical Innovations, LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Panniculus skin-adhesive retractor, reusable.
- ABBy — Clinical Innovations, LLC · Class I
- ABBy — Clinical Innovations, LLC · Class I
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
- Clinical Innovations, LLC
Sources (1)
- FDA UDI 27aef7fd-25cc-4ec6-a672-20de8d697427 33 fields · synced Jun 9, 2026