FDA.reportPublic FDA data

RZ Medizintechnik GmbH

Primary DI
04049197263863
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
320-170-260
Catalog number
320-170-260
Device description
Legueu Bladder Spatula 26.0cm
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
FGNRETRACTOR, NON-SELF-RETAINING

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FGNRetractor, Non-Self-RetainingGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04049197263863PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04049197263863040491972638634049197263863

GMDN Terms#

Term, Definition table
TermDefinition
Bladder spatulaA hand-held surgical instrument designed to manipulate, typically by lifting, the bladder during a surgical intervention in the abdominal cavity. It typically consists of a large flat blunt blade (no sharp edges) at the distal end that is set at a right angle to the handle and curved so that the surgeon can manipulate the organ from its underside; it has a strong handle at the proximal end. It is usually made of stainless steel and is available in a variety of blade designs (e.g., curved upwards with a flat rounded end). The blade and handle can be designed to be at various ergonomic angles to each other. 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

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Primary DI, Brand, Company table
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B382SD9070791100Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD9073531010Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD90738400T0Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD9073931130Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B382SD974411110Surgical DirectSurgical Direct, Inc.FGN2026-07-17
B803NL97020450ORTHOMEDORTHO-MED, INC.FGN2026-06-25
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B803NL97020150ORTHOMEDORTHO-MED, INC.FGN2026-06-23
B803NL97020200ORTHOMEDORTHO-MED, INC.FGN2026-06-23
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