Identity
- Trade Name
- Eigr™ Waveguide FDA UDI
- Generic Name
- Surgical instrument fibreoptic light FDA UDI
- Device Name
- The Eigr Waveguide, Narrow/Flat, LC is intended to provide surgical site illumination from a high intensity light source. FDA UDI
- Model / Reference
- Narrow / Flat, LC FDA UDI
- Description
- The Eigr Waveguide, Narrow/Flat, LC is intended to provide surgical site illumination from a high intensity light source. FDA UDI
Identifiers
- Catalog Number
- CEW1NF FDA UDI
- Primary DI / UDI-DI
- 00816728020059 FDA UDI
- 510(k) Number
- K090070 FDA UDI
- FDA Product Code
- FST FDA UDI
- GMDN Term
- Surgical instrument fibreoptic light 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
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Surgical instrument fibreoptic light
Eigr™ Waveguide by Invuity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical instrument fibreoptic light.
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- CoreLink Bifurcated Illuminator — LUMITEX, INC. · Class I
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- Fiber Optic Light Cable — GULF FIBEROPTICS, INC. · Class I
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC. · Class I
Cleared under the same submission
K090070 also covers:
- Breiten Sterilization Tray — INVUITY, INC.
- Breiten Sterilization Tray — 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.
- 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 cf9457e9-fe2f-4359-82ba-ce5f753a787b 37 fields · synced May 30, 2026