Identity
- Trade Name
- Strauss Surgical FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Model / Reference
- STS-LC-XLS-4.8 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00851925007779 FDA UDI
- 510(k) Number
- K021931 FDA UDI
- FDA Product Code
- FFS FDA UDIHBI FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.1500 FDA UDI878.4580 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Fibreoptic light cable
Strauss Surgical by American Medical Endoscopy — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Fibreoptic light cable.
- JEDMED — JEDMED Instrument Company · Class I
- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- Gimmi — Gimmi GmbH · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- Surgical Direct — SURGICAL DIRECT, INC. · Class II
- FENTEX — FENTEX medical GmbH · Class I
Cleared under the same submission
K021931 also covers:
- Strauss Surgical — AMERICAN MEDICAL ENDOSCOPY
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC.
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 c97737ea-9f73-4cbc-b117-c356049caaed 33 fields · synced Jun 1, 2026