FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197271578
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
350-622-008
Catalog number
350-622-008
Device description
Recamier curette blunt, malleable, 8 mm, Fig. 2
Published
2024-06-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTFCURETTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTFCuretteGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197271578PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197271578040491972715784049197271578

GMDN Terms#

Term, Definition table
TermDefinition
Intrauterine curette, manualA heavy, hand-held, surgical instrument with an open ring-shaped or fenestrated tip at the distal end of a long shaft that is used to scrape the lining of the uterus for the removal of tissue during a gynaecological procedure, typically for the removal of an early or non-viable embryo/foetus. The device is typically made of high-grade stainless steel and can be either rigid or malleable (bendable), and have a sharp or blunt scraping tip which is available in various shapes and sizes; it has a handle at the proximal end. 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
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04049197177603RZ Medizintechnik GmbH253-000-097253-000-0972025-09-22
04049197393393RZ Medizintechnik GmbH253-000-084253-000-0842025-09-22
04049197495325RZ Medizintechnik GmbH253-000-320253-000-3202025-09-22
04049197495387RZ Medizintechnik GmbH253-000-332253-000-3322025-09-22
04049197177368RZ Medizintechnik GmbH253-000-044253-000-0442025-07-30
04049197177467RZ Medizintechnik GmbH253-000-047253-000-0472025-07-30
04049197177580RZ Medizintechnik GmbH253-000-094253-000-0942025-07-30
04049197177801RZ Medizintechnik GmbH253-000-200253-000-2002025-07-30
04049197178082RZ Medizintechnik GmbH253-000-201253-000-2012025-07-30
04049197178150RZ Medizintechnik GmbH253-000-210253-000-2102025-07-30
04049197178167RZ Medizintechnik GmbH253-000-211253-000-2112025-07-30
04049197178501RZ Medizintechnik GmbH253-000-258253-000-2582025-07-30
04049197178563RZ Medizintechnik GmbH253-000-352253-000-3522025-07-30
04049197178570RZ Medizintechnik GmbH253-000-356253-000-3562025-07-30
04049197178723RZ Medizintechnik GmbH253-000-358253-000-3582025-07-30
04049197178730RZ Medizintechnik GmbH253-000-366253-000-3662025-07-30
04049197178747RZ Medizintechnik GmbH253-000-368253-000-3682025-07-30
04049197178822RZ Medizintechnik GmbH253-000-524253-000-5242025-07-30
04049197178839RZ Medizintechnik GmbH253-000-527253-000-5272025-07-30
04049197178846RZ Medizintechnik GmbH253-000-552253-000-5522025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
24026704941692PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
24026704941708PILLINGTELEFLEX INCORPORATEDHTF2026-03-23
00192896122871Spoon CuretteSONTEC INSTRUMENTS, INC.HTF2026-03-19
00810158219052PRINCETONPrinceton Medical Group, Inc.HTF2026-03-11
00190776393229MillenniumAvalign Technologies, Inc.HTF2026-03-04
00810168190297NAPACIFIC INSTRUMENTS, INC.HTF2026-03-03
00190776417260MillenniumAvalign Technologies, Inc.HTF2026-02-20
00190776416447MillenniumAvalign Technologies, Inc.HTF2026-02-16
00190776416669MillenniumAvalign Technologies, Inc.HTF2026-02-16
03662663109475Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109512Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109529Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109543Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109550Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
03662663109567Mergence-A Preparation InstrumentationHighridge Medical, LLCHTF2026-02-11
00190776416010MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416027MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416041MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416058MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776416065MillenniumAvalign Technologies, Inc.HTF2026-02-06
00190776415785MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415792MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415808MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415815MillenniumAvalign Technologies, Inc.HTF2026-02-04
00190776415822MillenniumAvalign Technologies, Inc.HTF2026-02-04
03662663083584ActivLHighridge Medical, LLCHTF2026-02-03
03662663083591ActivLHighridge Medical, LLCHTF2026-02-03
03662663083607ActivLHighridge Medical, LLCHTF2026-02-03
03662663083614ActivLHighridge Medical, LLCHTF2026-02-03
03662663083621ActivLHighridge Medical, LLCHTF2026-02-03