FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197270229
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
350-429-260
Catalog number
350-429-260
Device description
"Beacham Amniotome 26.0 cm, 10 1/4"" "
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197270229PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197270229040491972702294049197270229

GMDN Terms#

Term, Definition table
TermDefinition
Amniotome, reusableA surgical instrument used to cut/rupture the amniotic membrane (i.e., the amnion - the thin, tough membrane that lines the chorion and contains the foetus and the amniotic fluid) to assist in childbirth, without causing injury to the mother or foetus. It is long and shaft-like, and terminates in a sharp hook or protected blade used to rupture the membrane. It is typically made of high-grade stainless steel, and may be curved to follow the natural contours of the birthing canal into which it is inserted. Amniotic membrane rupture may also be performed using an amniotic perforator or forceps and/or a trocar. 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
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04
00190776427993MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776428167MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776427559MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427665MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427740MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427764MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427771MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427788MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427795MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776420369MillenniumAvalign Technologies, Inc.GEN2026-08-25
00190776418236MillenniumAvalign Technologies, Inc.GEN2026-08-23
00190776427238MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427269MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427276MillenniumAvalign Technologies, Inc.GEN2026-08-21
B382SD914775290Surgical DirectSurgical Direct, Inc.GEN2026-08-21
00190776417727MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776426767MillenniumAvalign Technologies, Inc.GEN2026-08-19
00190776417109MillenniumAvalign Technologies, Inc.GEN2026-08-18
00198506094002ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00198506094057ELMED INCORPORATEDELMED INCORPORATEDGEN2026-08-18
00190776425838MillenniumAvalign Technologies, Inc.GEN2026-08-17
G453333630140PEAK MEDICALPeak Medical Distribution Inc.GEN2026-08-14
00190776423544MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776423735MillenniumAvalign Technologies, Inc.GEN2026-08-07
00190776424404MillenniumAvalign Technologies, Inc.GEN2026-08-07
B382SD9238971100Surgical DirectSurgical Direct, Inc.GEN2026-08-07
00190776408763MillenniumAvalign Technologies, Inc.GEN2026-08-03