FDA.report

NA

Primary DI
04049197514583
Brand
NA
Company
RZ-Medizintechnik GmbH
Model
259-375-130
Catalog number
259-375-130
Device description
Spine Endoscope, 6.3 x 130mm, 30°
Published
2023-03-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
HRXArthroscope

Product Code Classifications

CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197514583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197514583040491975145834049197514583

GMDN Terms

TermDefinition
Diskectomy system, percutaneous, automaticAn automated system intended for the percutaneous (through the skin) removal of the nucleus pulposus from the lumbar disc. This system is used to resect and aspirate the nucleus pulposus in one step, eliminating the need for repeated insertion of the nucleotome. It provides an alternative to surgical diskectomy and is typically carried out under local anaesthesia. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
312953227
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

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04049197393393RZ Medizintechnik GmbH253-000-084253-000-0842025-09-22
04049197495325RZ Medizintechnik GmbH253-000-320253-000-3202025-09-22
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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

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