Identity
- Trade Name
- Strauss Surgical FDA UDI
- Generic Name
- Rigid optical nephroscope FDA UDI
- Model / Reference
- STS-5135-320HA FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851925007298 FDA UDI
- FDA Product Code
- FGA FDA UDI
- GMDN Term
- Rigid optical nephroscope 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
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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Safe FDA UDI
Category: Rigid optical nephroscope
Strauss Surgical by American Medical Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Rigid optical nephroscope.
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- Nephroscope — SOPRO-COMEG GmbH · Class II
- Nephroscope — SOPRO-COMEG GmbH · Class II
- Olympus — Olympus Winter & Ibe GmbH · Class II
- PANOVIEW — Richard Wolf GmbH · Class II
- Nephroscope — SOPRO-COMEG GmbH · Class II
- Nephroscope — SOPRO-COMEG GmbH · 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 |
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Manufacturer
- Manufacturer
- American Medical Endoscopy
Sources (1)
- FDA UDI 0052a0e2-c5a5-4e91-a3db-86b18830b862 32 fields · synced Jun 8, 2026