Novilase Laser Therapy Pack

Primary DI
00860011448006
Brand
Novilase Laser Therapy Pack
Company
Novian Health Inc.
Model
Switzerland: 150 mm
Catalog number
100011-03
Device 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.
Published
2023-12-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860011448006PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860011448006008600114480068600114480060860011448006

GMDN Terms#

Term, Definition table
TermDefinition
General/multiple surgical laser system beam guide, single-useA surgical device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials; a fibreoptic cable may be included with the device. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
3122667200info@novianhealth.com

Regulatory Flags#

DUNS number
011736427
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860008944870NovilaseLTS 2.1 (EU/Switzerland)100001-022023-11-15
00860008944887NovilaseLTS 2.1 (UK)100001-032023-11-15
00860008944825NovilaseLTS 2.1 (USA)100001-012023-11-12
00196852073344Novilase Laser Therapy PackSwitzerland: 150 mm100011-032023-11-15
00860008944818Novilase Laser Therapy PackUSA/EU/UK: 150 mm100011-012023-11-15
00860008944894Novilase Laser Therapy PackSwitzerland: 110 mm100011-042023-11-15
00860008944801Novilase Laser Therapy PackUSA/EU/UK: 110 mm100011-022023-11-12