FDA.report

Trephine Protection Tube

Primary DI
04049197524469
Brand
Trephine Protection Tube
Company
RZ-Medizintechnik GmbH
Model
259-160-560
Device description
Trephine Protection Tube, 6.0 x 160mm
Published
2023-05-02
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
HWKTrephine

Product Code Classifications

CodeDeviceSpecialtyClass
HWKTrephineOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
04049197524469PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197524469040491975244694049197524469

GMDN Terms

TermDefinition
Orthopaedic implant aiming/guiding block, reusableA surgical, jig-like device designed as a preshaped block with a defined pattern of prefabricated holes used to guide other instruments [e.g., drill sleeves and guide wires (Kirschner wires)] and/or to align a corresponding implant (e.g., a fixation plate) during an orthopaedic procedure. It is typically made of metallic or synthetic materials and may have an attachment point for an implant. 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
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
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04049197177603RZ Medizintechnik GmbH253-000-097253-000-0972025-09-22
04049197393393RZ Medizintechnik GmbH253-000-084253-000-0842025-09-22
04049197495325RZ Medizintechnik GmbH253-000-320253-000-3202025-09-22
04049197495387RZ Medizintechnik GmbH253-000-332253-000-3322025-09-22
04049197177368RZ Medizintechnik GmbH253-000-044253-000-0442025-07-30
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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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