Identity
- Trade Name
- CRH O'Regan System FDA UDI
- Generic Name
- Haemorrhoid ligator FDA UDI
- Device Name
- A case containing 20 Individually sealed kits, each kit containing one ligator with obturator, a bag of 3 latex bands, a loading cone and a patient brochure. FDA UDI
- Model / Reference
- 11-4120 FDA UDI
- Description
- A case containing 20 Individually sealed kits, each kit containing one ligator with obturator, a bag of 3 latex bands, a loading cone and a patient brochure. FDA UDI
Identifiers
- Catalog Number
- 11-4120 FDA UDI
- Primary DI / UDI-DI
- 17540192000018 FDA UDI
- FDA Product Code
- FHN FDA UDI
- GMDN Term
- Haemorrhoid ligator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
Yes
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
No
FDA UDI
Category: Haemorrhoid ligator
CRH O'Regan System by CRH Medical Corporation — Class II — 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 II | Pending data |
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Manufacturer
- Manufacturer
- CRH Medical Corporation
Sources (1)
- FDA UDI 117c9ae9-f181-4220-a616-d427d5fef7a9 34 fields · synced Jun 8, 2026