FDA.report

RZ Medizintechnik GmbH

Primary DI
04049197118484
Brand
RZ Medizintechnik GmbH
Company
RZ-Medizintechnik GmbH
Model
210-137-005
Catalog number
210-137-005
Device description
Lambotte mini osteotome, curved 4 mm, 12.5cm
Published
2024-10-02
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
HWMOSTEOTOME

Product Code Classifications

CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197118484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197118484040491971184844049197118484

GMDN Terms

TermDefinition
Orthopaedic osteotomeA chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

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
true

Other Devices From This Company

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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
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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
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