Identity
- Trade Name
- PhotonGuide FDA UDI
- Generic Name
- Surgical instrument fibreoptic light FDA UDI
- Device Name
- The PhotonGuide is intended to provide surgical site illumination from a high intensity light source. FDA UDI
- Model / Reference
- Narrow / Angled FDA UDI
- Description
- The PhotonGuide is intended to provide surgical site illumination from a high intensity light source. FDA UDI
Identifiers
- Catalog Number
- 104001 FDA UDI
- Primary DI / UDI-DI
- 00816728020097 FDA UDI
- FDA Product Code
- FSZ 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
Yes
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
PhotonGuide by Invuity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument fibreoptic light.
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- CoreLink Bifurcated Illuminator — LUMITEX, INC. · Class I
- Pinnacle Spine Products Surgical Illuminator — LUMITEX, INC. · Class I
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC. · Class I
- Fiber Optic Light Cable — GULF FIBEROPTICS, INC. · Class I
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 312d5237-6c21-40f9-a255-bdbb5a5c919e 36 fields · synced Jun 8, 2026