FDA.report

RZ Medizintechnik GmbH

Primary DI
04049197473255
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
410-360-500
Catalog number
410-360-500
Device description
McGee Malleus Crimper, large model, 80mm working length
Published
2024-09-20
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

Related Records

Contact Domains

Product Codes

CodeName
HYAFORCEPS, WIRE HOLDING

Product Code Classifications

CodeDeviceSpecialtyClass
HYAForceps, Wire HoldingGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197473255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197473255040491974732554049197473255

GMDN Terms

TermDefinition
Wire holding/twisting forcepsA surgical instrument with specially designed sturdy blades used to grip, tighten and/or twist wires that are being applied to the patient during a surgical intervention. It typically has a scissors-like design with ring handles, is made of high-grade stainless steel and may be self-retaining. It is available in various sizes and the working end can have a variety of jaw designs, e.g., typically short and broad with carbide inserts, but some may be long with side protruding posts around which the loose end of the wire are secured to provide greater grip. The blades/handles are typically strong in profile. This is a reusable device.

Sterilization Methods

Method

Contacts

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
false

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