FDA.reportPublic FDA data

CATHETER POUR CYSTOMETRIE 2 VOIES CH 6

Primary DI
03665039010832
Brand
CATHETER POUR CYSTOMETRIE 2 VOIES CH 6
Company
PRINCE MEDICAL
Model
VS1480640
Catalog number
VS1480640
Published
2021-10-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FENDevice, Cystometric, Hydraulic
KODCatheter, Urological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FENDevice, Cystometric, HydraulicGastroenterology, Urology2
KODCatheter, UrologicalGastroenterology, Urology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665039010832PackageGS150In Commercial Distribution
03665039002417PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665039010832036650390108323665039010832
03665039002417036650390024173665039002417

GMDN Terms#

Term, Definition table
TermDefinition
Urodynamic manometric catheter, non-electronicA sterile, non-electrical, long flexible tube intended to be inserted into the bladder via the urethra, or a stoma, for measuring urethral/bladder pressure, urinary output, other urethral and voiding pressures, and/or cystometry. The measuring method employed is typically the infusion of water (water-perfused catheter) or insufflation of air/gas (air-charged catheter) into the catheter, whereby pressure signals are conducted to proximally-connected external pressure transducers in urodynamic examination equipment. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
0344265476clement.gallois@omerin.com

Regulatory Flags#

DUNS number
569442924
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
true
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665039001656Endoline VIPERSN3980718SN39807182024-01-30
03665039001663Endoline PUNCSN4000718SN40007182024-01-30
03665039005630Extraction Kit B-4815B-48152024-01-30
03665039002417CATHETER POUR CYSTOMETRIE 2 VOIES CH 6VS1480640VS14806402021-10-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10192253029079DoverCardinal Health 200, LLCKOD2025-04-07
10192253029086DoverCardinal Health 200, LLCKOD2025-04-07
10192253029093DoverCardinal Health 200, LLCKOD2025-04-07
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10192253029116DoverCardinal Health 200, LLCKOD2025-04-07
10192253029123DoverCardinal Health 200, LLCKOD2025-04-07
10192253030310DoverCardinal Health 200, LLCKOD2025-04-07
10192253030327DoverCardinal Health 200, LLCKOD2025-04-07
10192253030334DoverCardinal Health 200, LLCKOD2025-04-07
10192253030341DoverCardinal Health 200, LLCKOD2025-04-07
10192253030358DoverCardinal Health 200, LLCKOD2025-04-07
10192253030365DoverCardinal Health 200, LLCKOD2025-04-07
10192253030648DoverCardinal Health 200, LLCKOD2025-01-15
10192253031041DoverCardinal Health 200, LLCKOD2025-01-15
10192253031423DoverCardinal Health 200, LLCKOD2025-01-15
10192253030624DoverCardinal Health 200, LLCKOD2025-01-14
10192253031409DoverCardinal Health 200, LLCKOD2025-01-14
10192253031416DoverCardinal Health 200, LLCKOD2025-01-14
10192253038897DoverCardinal Health 200, LLCKOD2025-01-14
10192253030303DoverCardinal Health 200, LLCKOD2024-07-10
10192253024326DoverCardinal Health 200, LLCKOD2024-02-29
10192253024333DoverCardinal Health 200, LLCKOD2024-02-29
10192253024357DoverCardinal Health 200, LLCKOD2024-02-29
10192253030457DoverCardinal Health 200, LLCKOD2024-02-29
10192253030464DoverCardinal Health 200, LLCKOD2024-02-29