FDA.reportPublic FDA data

Metal catheter

Primary DI
04049197264440
Brand
Metal catheter
Company
RZ-Medizintechnik GmbH
Model
320-721-080
Device description
Metal catheter for women 8 Fr.,15cm
Published
2023-08-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
GBZCatheter, Cholangiography

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GBZCatheter, CholangiographyGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197264440PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197264440040491972644404049197264440

GMDN Terms#

Term, Definition table
TermDefinition
Ureteral catheterA flexible tube designed for introduction into the ureters through a cystoscope, ureteroscope or nephroscope. It is typically a 3 to 12 Fr radiopaque tube with one of several tip configurations (e.g., straight, bent, olive). It may have a single or double-lumen and graduated markings. The device is used for ureter dilation, bypass of partial obstructions, urinary tract irrigation/drainage during surgery (e.g., injection of contrast agent, anaesthetic agent and/or antiretropulsion gel), stone removal, retrograde urography, guidewire placement, and/or brush biopsy. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
312953227
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049197152594RZ Medizintechnik GmbH250-035-180250-035-1802024-10-16
04049197152624RZ Medizintechnik GmbH250-035-300250-035-3002024-10-16
04049197152648RZ Medizintechnik GmbH250-037-000250-037-0002024-10-16
04049197152662RZ Medizintechnik GmbH250-039-000250-039-0002024-10-16
04049197152679RZ Medizintechnik GmbH250-040-000250-040-0002024-10-16
04049197152686RZ Medizintechnik GmbH250-041-000250-041-0002024-10-16
04049197152693RZ Medizintechnik GmbH250-042-000250-042-0002024-10-16
04049197152723RZ Medizintechnik GmbH250-044-000250-044-0002024-10-16
04049197152747RZ Medizintechnik GmbH250-045-000250-045-0002024-10-16
04049197152754RZ Medizintechnik GmbH250-048-000250-048-0002024-10-16
04049197152761RZ Medizintechnik GmbH250-048-180250-048-1802024-10-16
04049197152778RZ Medizintechnik GmbH250-048-230250-048-2302024-10-16
04049197152785RZ Medizintechnik GmbH250-048-300250-048-3002024-10-16
04049197152860RZ Medizintechnik GmbH250-053-180250-053-1802024-10-16
04049197152877RZ Medizintechnik GmbH250-054-180250-054-1802024-10-16
04049197390668RZ Medizintechnik GmbH250-035-230250-035-2302024-10-16
04049197390675RZ Medizintechnik GmbH250-038-000250-038-0002024-10-16
04049197390729RZ Medizintechnik GmbH250-051-000250-051-0002024-10-16
04049197390743RZ Medizintechnik GmbH250-052-000250-052-0002024-10-16
04049197390750RZ Medizintechnik GmbH250-053-230250-053-2302024-10-16

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810158211872PRINCETONPrinceton Medical Group, Inc.GBZ2024-07-30
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00733132657902GORE TIPS SetW. L. Gore & Associates, Inc.GBZ2024-07-15
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G587MAS0070PRINCETONPrinceton Medical Group, Inc.GBZ2023-12-14
04049197181631Guyon Catheters RZ-Medizintechnik GmbHGBZ2023-08-16
04049197264310Metal CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466059FOLEY CatheterRZ-Medizintechnik GmbHGBZ2023-08-16
04049197466080Rotunda KatheterRZ-Medizintechnik GmbHGBZ2023-08-16
B80291000american catheter CORPAmerican Catheter Corp.GBZ2023-06-20
00827002217652COOKCOOK INCORPORATEDGBZ2022-12-08
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