FDA.report

TRIGEN MAX IM REAMER HEAD 16 MM, FRONT CUTTING

Primary DI
07640187918052
Brand
TRIGEN MAX IM REAMER HEAD 16 MM, FRONT CUTTING
Company
MPS Micro Precision Systems AG
Model
T18775
Catalog number
T18775
Device description
Intramedullary reamer head is used in combination with the Intramedullary reamer shaft to ream the medullary cavity of long bones in traumatologic or limb lengthening surgery of the femur, tibia and humerus bones where medullary cavities need to be prepared prior to placing a nail. The intramedullary reamers are intended for use with a guide wire to permit to secure the assembly and a surgical drilling machine. The device is reusable.
Published
2025-01-22
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
HTOReamer

Product Code Classifications

CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07640187918052PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07640187918052076401879180527640187918052

GMDN Terms

TermDefinition
Medullary canal orthopaedic reamer, flexibleAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long cylindrical device with straight, spiralled or contoured flutes acting as the cutting surfaces that is attached to a flexible shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy; it comes in varying sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
999-999-9999vigilance.biel@mpsag.com

Regulatory Flags

DUNS number
482204059
Device count
1
DM exempt
true
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
07640187918137IM reamer shaft dove tail 470 mm, Hudson coup.T18819T188192025-05-30
07640187918144IM reamer shaft dove tail 470 mm, Stryker/Zimmer-Hall coup.T18820T188202025-05-30
07640187918151IM reamer shaft dove tail 470 mm, Big AO coup.T18821T188212025-05-30
07640187918168Straight guide Ø2 x 820 mmT18822T188222025-05-30
07640187918175Straight guide Ø3 x 820 mmT18823T188232025-05-30
07640187918243IM reamer head dove tail Ø9 x 21 mm, can. Ø3.4 mmT18830T188302025-05-30
07640187918250IM reamer head dove tail Ø10 x 23 mm, can. Ø3.4 mmT18831T188312025-05-30
07640187918267IM reamer head dove tail Ø11 x 24 mm, can. Ø3.4 mmT18832T188322025-05-30
07640187918274IM reamer head dove tail Ø12 x 25 mm, can. Ø3.4 mmT18833T188332025-05-30
07640187918281IM reamer head dove tail Ø13 x 27 mm, can. Ø3.4 mmT18834T188342025-05-30
07640187918298IM reamer head dove tail Ø14 x 28 mm, can. Ø3.4 mmT18835T188352025-05-30
07640187918304IM reamer head dove tail Ø15 x 29 mm, can. Ø3.4 mmT18836T188362025-05-30
07640187918311IM reamer head dove tail Ø16 x 30 mm, can. Ø3.4 mmT18837T188372025-05-30
07640187918328IM reamer head dove tail Ø17 x 31 mm, can. Ø3.4 mmT18838T188382025-05-30
07640187918335IM reamer head dove tail Ø18 x 32 mm, can. Ø3.4 mmT18839T188392025-05-30
07640187918342IM reamer head dove tail Ø19 x 33 mm, can. Ø3.4 mmT18840T188402025-05-30
07640187918359IM reamer head dove tail Ø20 x 34 mm, can. Ø3.4 mmT18841T188412025-05-30
07640187918366IM reamer head dove tail Ø21 x 35 mm, can. Ø3.4 mmT18867T188672025-05-30
07640187918373IM reamer head dove tail Ø22 x 36 mm, can. Ø3.4 mmT18868T188682025-05-30
07640187918380IM reamer head dove tail Ø23 x 38 mm, can. Ø3.4 mmT18869T188692025-05-30

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