Identity
- Trade Name
- Light Jacket FDA UDI
- Generic Name
- Operating room light FDA UDI
- Device Name
- The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil. FDA UDI
- Model / Reference
- PM-LJ100 FDA UDI
- Description
- The Light Jacket® Attachable Light for Electrosurgical Pencil is offered as a sterile, one-time use disposable medical device for providing enhanced illumination of the surgical site when attached to an electrosurgical pencil. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860000230711 FDA UDI
- FDA Product Code
- FTD FDA UDI
- GMDN Term
- Operating room 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: Operating room light
Light Jacket by Pathy Medical, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Operating room light.
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- HarmonyAIR — STERIS CORPORATION · Class II
- Medical Boom — Amico Clinical Solutions Corp · Class II
- iCE Surgical Light — Amico Clinical Solutions Corp · Class II
- HarmonyAIR — STERIS CORPORATION · Class II
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
- Pathy Medical, Llc
Sources (1)
- FDA UDI 8e1ddfbb-d6f5-4a66-a817-5bb32408c905 36 fields · synced Jun 1, 2026