FDA.reportPublic FDA data

InterV Flex Catheter

Primary DI
15056033811252
Brand
InterV Flex Catheter
Company
PAN MEDICAL US CORPORATION
Model
INTVMN-15-FL
Catalog number
INTVMN-15-FL
Device description
11 Gauge 15mm Balloon Kyphoplasty Flex Catheter (Mini)
Published
2019-06-05
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#

Product Codes#

Code, Name table
CodeName
HRXArthroscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
15056033811252PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1505603381125215056033811252

GMDN Terms#

Term, Definition table
TermDefinition
Kyphoplasty balloon catheterA sterile, flexible tube designed to be used for the creation of a void within a vertebral body during a minimally invasive procedure commonly known as balloon kyphoplasty. It is manually inserted percutaneously through an access channel under fluoroscopic guidance to a vertebral compression fracture (VCF) site (e.g., in the lumbar or thoracic region of the spine) where its balloon is inflated with a medium (e.g., a liquid contrast medium) to force the vertebrae apart for insertion of bone cement; thereafter it is deflated and removed via the access channel. This is a single-use device.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
(727) 914-3932PanMed@PanMed.US

Regulatory Flags#

DUNS number
080228535
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
15056033810538OsteoflexINTV-CEM2016-11-04
15060270904295InterV Flex CatheterINTVMN-20-FLINTVMN-20-FL2019-06-05
15060270907937InterV-Curve PlusINTVMC-15-LINTVMC-15-L2019-06-05
15060270907944InterV-Curve PlusINTVMC-20-LINTVMC-20-L2019-06-05
15060270904257InterVINTVMC-10INTVMC-102019-05-15
15060270904264InterVINTVMC-15INTVMC-152019-05-15
15060270904271InterVINTVMC-20INTVMC-202019-05-15
15060270907913InterV-Curve PlusINTVMC-10-LINTVMC-10-L2019-05-15
15060270908880InterVINTVMN-10INTVMN-102019-05-15
15060270908897InterVINTVMN-15INTVMN-152019-05-15
15060270908903InterVINTVMN-20INTVMN-202019-05-15
15060270905155InterVINTVM-10INTVM-102019-05-14
15060270905179InterVINTVM-15INTVM-152019-05-14
15060270905186InterVINTVM-20INTVM-202019-05-14
15060270906251InterVINTV-10INTV-102019-05-14
15060270906268InterVINTV-15INTV-152019-05-14
15060270906275InterVINTV-20INTV-202019-05-14

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