FDA.report

Trephine

Primary DI
04049197515078
Brand
Trephine
Company
RZ-Medizintechnik GmbH
Model
259-660-225
Device description
Trephine, 6.6 x 225mm
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
04049197515078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
04049197515078040491975150784049197515078

GMDN Terms

TermDefinition
Bone trephineAn orthopaedic surgical blade designed to cut and remove circular sections of bone, typically for biopsy or percutaneous bone graft harvesting. It is typically a hollow cylinder with a circular, saw-like serrated working edge. It is an exchangeable device that may be attached to a manually-operated handle or to a powered rotary surgical handpiece. The device is typically made of high-grade stainless steel. 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
04049197177467RZ Medizintechnik GmbH253-000-047253-000-0472025-07-30
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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B756STR00108SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00109SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00110SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00111SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00112SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00113SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00114SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00115SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00116SP0Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00117SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00118SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00119SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00120SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21
B756STR00121SP1Shukla Trephine S9TREPHINEShukla MedicalHWK2024-08-21