Identity
- Trade Name
- Cystosure FDA UDI
- Generic Name
- Rigid optical cystoscope FDA UDI
- Device Name
- Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long FDA UDI
- Model / Reference
- 10-330 FDA UDI
- Description
- Cystosure Scope, 30 deg, 2.7 mm OD, 270 mm long FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00866403000265 FDA UDI
- FDA Product Code
- FAJ FDA UDI
- GMDN Term
- Rigid optical cystoscope FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 2.7 Millimeter FDA UDIShaft Length — 270 Millimeter FDA UDI
Category: Rigid optical cystoscope
Cystosure by Emmy Medical — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical cystoscope.
- Millennium — AVALIGN TECHNOLOGIES, Inc. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY · Class II
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- IEC-Innoview GmbH — INNOVATIVE ENDOSCOPY COMPONENTS, L.L.C. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
- AED — NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Emmy Medical
Sources (1)
- FDA UDI 0e509e9f-4c43-44e7-b2ac-6aea152e2109 35 fields · synced May 30, 2026