Identity
- Trade Name
- Surgical Direct FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- 5mm 10' Autoclavable Fiber Optic Light Cable, Blue ..Light Source Type: Wolf, Dyonics, and Stryker X8000 and L9000..Scope Type: Acmi/Circon, Bare Post Clip On FDA UDI
- Model / Reference
- SD8453115 FDA UDI
- Description
- 5mm 10' Autoclavable Fiber Optic Light Cable, Blue ..Light Source Type: Wolf, Dyonics, and Stryker X8000 and L9000..Scope Type: Acmi/Circon, Bare Post Clip On FDA UDI
Identifiers
- Catalog Number
- SD8453115 FDA UDI
- Primary DI / UDI-DI
- B382SD84531150 FDA UDI
- 510(k) Number
- K021931 FDA UDI
- FDA Product Code
- FFS FDA UDI
- GMDN Term
- Fibreoptic light cable 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Dimensions & Sizes
- Size
- Length — 10 Feet FDA UDIOuter Diameter — 5 Millimeter FDA UDI
Category: Fibreoptic light cable
Surgical Direct by Surgical Direct, Inc. — 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
- Gimmi — Gimmi GmbH · Class II
- ASSI — ACCURATE SURGICAL & SCIENTIFIC INSTRUMENTS CORP. · Class II
- JEDMED — JEDMED Instrument Company · Class I
- FENTEX — FENTEX medical GmbH · Class I
- Gimmi — Gimmi GmbH · Class II
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC. · Class II
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
- Surgical Direct, Inc.
Sources (1)
- FDA UDI 931783c0-aa26-4ed8-83d7-cb55f8efb38a 37 fields · synced Jun 6, 2026