FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197181815
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
253-323-225
Catalog number
253-323-225
Device description
Dittel Dilating Bougies Charr. 11, straight, 22.5cm
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FAXBOUGIE, UROLOGICAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FAXBougie, UrologicalGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197181815PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197181815040491971818154049197181815

GMDN Terms#

Term, Definition table
TermDefinition
Urethral dilator, reusableA slender, solid or hollow, flexible or semi-flexible, surgical instrument designed to dilate the urethra, mainly to treat strictures of the urethra, to facilitate the extraction of stones (renal calculi), and/or to facilitate catheter placement. It is typically made of metal or plastics and is available in a range of sizes; it may include a mechanical expanding mechanism. The device may also include a dial to show the degree of expansion of the urethra and as such is usually considered a urethrometer. Urethral bougies are also used for urethral dilatation. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+49746294700info@rz-medizintechnik.com

Regulatory Flags#

DUNS number
312953227
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810143905809SURGIPROSSurgipros, LLCFAX2026-06-01
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00810143905823SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905830SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905847SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905854SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905861SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905878SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905885SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905892SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905908SURGIPROSSurgipros, LLCFAX2026-06-01
00810143905915SURGIPROSSurgipros, LLCFAX2026-06-01
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04049197181730RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181754RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181761RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181785RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181792RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181822RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181846RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181853RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181877RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181884RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181907RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181914RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181938RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181945RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28
04049197181969RZ Medizintechnik GmbHRZ-Medizintechnik GmbHFAX2024-06-28