Identity
- Trade Name
- Novilase Laser Therapy Pack FDA UDI
- Generic Name
- General/multiple surgical laser system beam guide, single-use FDA UDI
- Device Name
- Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland. FDA UDI
- Model / Reference
- Switzerland: 150 mm FDA UDI
- Description
- Procedure pack for Novilase Laser Therapy System containing single-use disposables for laser ablation procedure. Pack contains sterile kit with (1) 150 mm laser probe with removable stylet and 1 temperature sensor, (1) 150 mm thermal probe with 5 temperature sensors, (1) optical fiber, and (1) probe guide; and (1) 30 ml sterile syringe. For distribution in Switzerland. FDA UDI
Identifiers
- Catalog Number
- 100011-03 FDA UDI
- Primary DI / UDI-DI
- 00196852073344 FDA UDI
- GMDN Term
- General/multiple surgical laser system beam guide, single-use FDA UDI
Classification
- Commercial Distribution
- Not 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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Novilase Laser Therapy Pack by Novian Health Inc. — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 | N/A | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Novian Health Inc.
Sources (1)
- FDA UDI 7d05718c-6bec-4a01-9b9f-9203feaf7663 36 fields · synced Jun 9, 2026