FDA.report

TRIVEX

Primary DI
03596010442154
Brand
TRIVEX
Company
Smith & Nephew, Inc.
Model
7205944
Catalog number
7205944
Device description
MTO TRIVEX TM ITALIAN KIT 230-240V
Published
2015-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
GEIELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Product Code Classifications

CodeDeviceSpecialtyClass
GEIElectrosurgical, Cutting & Coagulation & AccessoriesGeneral, Plastic Surgery2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03596010442154PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03596010442154035960104421543596010442154

GMDN Terms

TermDefinition
Transillumination phlebectomy system control unitA mains electricity (AC-powered) device that is a component of a transillumination phlebectomy system intended to be used for the resection and ablation of varicose veins [superficial dilated tortuous veins especially of the legs (greater saphenous veins)]. It is used to supply the power and steering controls for the invasive devices of the system as well as provide the pump for irrigation of the surgical site.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)238-7538GUDID@SMITH-NEPHEW.COM

Regulatory Flags

DUNS number
109903521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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