Identity
- Trade Name
- Synthes Fiber Optic Cable FDA UDI
- Generic Name
- Fibreoptic light cable FDA UDI
- Device Name
- Intended to provide surgical site illumination from a high intensity light source. FDA UDI
- Model / Reference
- Single FDA UDI
- Description
- Intended to provide surgical site illumination from a high intensity light source. FDA UDI
Identifiers
- Catalog Number
- 115001, 03.809.733 FDA UDI
- Primary DI / UDI-DI
- 00816728020165 FDA UDI
- 510(k) Number
- K090070 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Fibreoptic light cable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4580 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
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 — 8 Feet FDA UDI
Category: Fibreoptic light cable
Synthes Fiber Optic Cable by Invuity, 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
- 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
K090070 also covers:
- Breiten Sterilization Tray — INVUITY, INC.
- Breiten Sterilization Tray — INVUITY, INC.
- Eigr™ Waveguide — INVUITY, INC.
- Eikon Sterilization Tray — INVUITY, INC.
- Invuity® Fiber Optic Cable — INVUITY, INC.
- Invuity® Fiber Optic Cable — INVUITY, INC.
- Invuity® Fiber Optic Sterilization Tray — INVUITY, INC.
- Invuity® Steam Sterilization Tray — INVUITY, INC.
- Invuity® Steam Sterilization Tray — INVUITY, INC.
- Invuity® Sterilization Tray — INVUITY, INC.
- Synthes Fiber Optic Cable — INVUITY, 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
- Invuity, Inc.
Sources (1)
- FDA UDI 9a6885ee-67fe-4c23-ae0d-ff7dcbff7794 37 fields · synced May 30, 2026