Identity
- Trade Name
- Strauss Surgical FDA UDI
- Generic Name
- Urogenital surgical laser system beam guide, single-use FDA UDI
- Model / Reference
- STS-LAS-940-SBR FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851925007625 FDA UDI
- 510(k) Number
- K201171 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Urogenital surgical laser system beam guide, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Urogenital surgical laser system beam guide, single-use
Strauss Surgical by American Medical Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K201171 also covers:
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
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 1bf23418-3af6-4ea1-86d7-619836be1533 33 fields · synced May 30, 2026