Identity
- Trade Name
- PhotonBlade® FDA UDI
- Generic Name
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
- Device Name
- The PhotonBlade Breast Kit consists of (1) PhotonBlade packaged with a (1) PhotonGuide, Wide / Angled illuminator for the convenience of the user. The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units. The PhotonGuide is intended to provide surgical site illumination from a high intensity light source. FDA UDI
- Model / Reference
- PhotonBlade Breast Kit FDA UDI
- Description
- The PhotonBlade Breast Kit consists of (1) PhotonBlade packaged with a (1) PhotonGuide, Wide / Angled illuminator for the convenience of the user. The PhotonBlade is an RF device coupled with illumination that is indicated for cutting and coagulation of soft tissue during surgical procedures. It is intended to be used with a variety of standard commercially available electrosurgical units. The PhotonGuide is intended to provide surgical site illumination from a high intensity light source. FDA UDI
Identifiers
- Catalog Number
- PBPG1 FDA UDI
- Primary DI / UDI-DI
- 00816728020523 FDA UDI
- 510(k) Number
- K162053 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Open-surgery electrosurgical electrode, monopolar, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 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
Yes
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: Open-surgery electrosurgical electrode, monopolar, single-use
PhotonBlade® by Invuity, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 e07bd0c2-eec4-4459-b3c5-0822a6e5310e 36 fields · synced Jun 8, 2026