Identity
- Trade Name
- Proctowash FDA UDI
- Generic Name
- Rectal medication applicator, single-use FDA UDI
- Device Name
- Proctowash Rectal Stump Washout Kit for elimination of exfoliated tumour cells from the rectal stump in colorectal cancer procedures. Rectal washout for intra-operative prepping of the rectum whenever required. Non-sterile. Comprised of 1 x Handset/probe with flexible atraumatic tip, 1 x 2.5m Giving Set, 1 x 0.8m Waste Tubing, 1 x 3l Cubitainer waste receptacle. FDA UDI
- Model / Reference
- PR01 FDA UDI
- Description
- Proctowash Rectal Stump Washout Kit for elimination of exfoliated tumour cells from the rectal stump in colorectal cancer procedures. Rectal washout for intra-operative prepping of the rectum whenever required. Non-sterile. Comprised of 1 x Handset/probe with flexible atraumatic tip, 1 x 2.5m Giving Set, 1 x 0.8m Waste Tubing, 1 x 3l Cubitainer waste receptacle. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060485740025 FDA UDI
- FDA Product Code
- FGM FDA UDI
- GMDN Term
- Rectal medication applicator, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.4730 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
No
FDA UDI
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
Category: Rectal medication applicator, single-useRectal medication/infusion catheter
Proctowash by Intermark Medical Innovations Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rectal medication/infusion catheter.
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
- Intermark Medical Innovations Limited
Sources (1)
- FDA UDI efce70e0-dd14-4264-81b1-8b60c72253a3 34 fields · synced May 30, 2026