Identity
- Trade Name
- Scope CleanOR FDA UDI
- Generic Name
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
- Device Name
- Scope and Trocar Cleaning Device FDA UDI
- Model / Reference
- SC-01 FDA UDI
- Description
- Scope and Trocar Cleaning Device FDA UDI
Identifiers
- Catalog Number
- SC-01 FDA UDI
- Primary DI / UDI-DI
- 09349967000656 FDA UDI
- FDA Product Code
- NWV FDA UDI
- GMDN Term
- Surgical instrument/endoscope cleaning utensil, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 884.1720 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
No
FDA UDI
Category: Surgical instrument/endoscope cleaning utensil, single-use
Scope CleanOR by The O R Company Pty Ltd — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument/endoscope cleaning utensil, single-use.
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- Cleaning Brushes for Endoscope — Changzhou Jiuhong Medical Instrument Co., Ltd. · Class I
- Cleaning Brushes — ZHEJIANG CHUANGXIANG MEDICAL TECHNOLOGY CO., LTD. · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brush — H.+H. Maslanka Chirurgische Instrumente GmbH · Class I
- Cleaning brushes — SANDERSON MACLEOD · 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
- The O R Company Pty Ltd
Sources (1)
- FDA UDI 1b951ef5-74ca-4408-ace6-a6d4ee27bf7a 34 fields · synced Jun 1, 2026