FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197467438
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
350-757-190
Catalog number
350-757-190
Device description
Doyen Myoma screw 170mm
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
MDMINSTRUMENT, MANUAL, SURGICAL, GENERAL USE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197467438PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197467438040491974674384049197467438

GMDN Terms#

Term, Definition table
TermDefinition
Myoma screw, reusableA hand-held manual surgical instrument designed to engage, stabilize, and manipulate a myoma (i.e., a uterine fibroid) and other gynaecological tissues during their surgical removal. It is typically a one-piece instrument designed as a corkscrew having a pointed helicoidal stainless steel screw at the distal end, with a long slender shaft and a handle at the proximal end; it may be inserted through another device (e.g., laparoscope, hysteroscope, trocar) or be used during open surgery. 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
08800042700102Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700140Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700256Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700270Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700287Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042700300Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700317Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700324Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042700386Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700393Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700416Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700423Artisential Needle HolderLIVSMEDMDM2026-04-29
08800042700843Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700850Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700874Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700881Artisential Precise Needle HolderLIVSMEDMDM2026-04-29
08800042700997Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701017Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701031Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701048Artisential Fenestrated ForcepsLIVSMEDMDM2026-04-29
08800042701062Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701086Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701093Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701109Artisential Maryland DissectorLIVSMEDMDM2026-04-29
08800042701116ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701123ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701130ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701147ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701154ArtiSential Precise DissectorLIVSMEDMDM2026-04-29
08800042701161ArtiSential Precise DissectorLIVSMEDMDM2026-04-29