Identity
- Trade Name
- Retrowash EUDAMEDFDA UDI
- Generic Name
- Colonic lavage kit, surgical FDA UDI
- Device Name
- Retrowash On-Table Lavage Kit EUDAMEDRetrowash On-Table Lavage/Bowel Washout Kit, 46mm version, for intra-operative washout of the colon in emergency obstructions. The 46mm version is for use where the bowel is distended. After washout, the device facilitates on-table colonoscopy if desired. Sterile. Comprised of 1 x 46mm Handpiece Assembly with 1.6m waste tubing; 1.5m Giving Set; 1.0m Extension Set; 4 x Ties; 2 x 10l Cubitainer waste receptacles. FDA UDI
- Model / Reference
- RW46 EUDAMEDFDA UDI
- Description
- Retrowash On-Table Lavage/Bowel Washout Kit, 46mm version, for intra-operative washout of the colon in emergency obstructions. The 46mm version is for use where the bowel is distended. After washout, the device facilitates on-table colonoscopy if desired. Sterile. Comprised of 1 x 46mm Handpiece Assembly with 1.6m waste tubing; 1.5m Giving Set; 1.0m Extension Set; 4 x Ties; 2 x 10l Cubitainer waste receptacles. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060485740018 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060485740018 EUDAMED
- FDA Product Code
- KOA FDA UDI
- EMDN Code
- G020102 INTESTINAL LAVAGE TUBES AND SETS EUDAMED
- GMDN Term
- Colonic lavage kit, surgical FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 876.4730 FDA UDI
- Market of Registration
- Northern Ireland 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
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
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
Dimensions & Sizes
- Size
- Outer Diameter — 46 Millimeter FDA UDI
Retrowash by Intermark Medical Innovations Ltd — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060485740018 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Intermark Medical Innovations Ltd
- EUDAMED SRN
- GB-MF-000007221
- Authorised Representative
- Intermark Medical (NI) Ltd XI-AR-000007141
Sources (2)
- EUDAMED cf85c5fc-a631-4068-bd77-cc0dfa054eb8 61 fields · synced Jul 9, 2026
- FDA UDI 27e854eb-1b2b-42e2-a4d5-bf54ac92bbcf 35 fields · synced May 29, 2026