FDA.reportPublic FDA data

Femoral IM reamer Ø16 x 483 mm, can. Ø3.1 mm Hudson coup.

Primary DI
07640187912067
Brand
Femoral IM reamer Ø16 x 483 mm, can. Ø3.1 mm Hudson coup.
Company
MPS Precimed SA
Model
T18161
Catalog number
T18161
Device description
Femoral monobloc intramedullary reamer is used to ream the medullary cavity of femoral bone prior to placing a nail. A range of diameter is proposed in regards with the nail to be implanted and a range of length is proposed in regards with the height of the bone. Different distal coupling are available to connect with existing power tool.
Published
2020-08-10
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187912067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187912067076401879120677640187912067

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
999-999-9999customers@mpsprecimed.com

Regulatory Flags#

DUNS number
486741981
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
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640187910476Allen key 3.5 mmT14927T149272020-08-26
07640187910483Extraction clampT14588T145882020-08-26
07640187910506PuncherT14586T145862020-08-26
07640187910537ClampT16813T168132020-08-26
07640187911343Straight guide Ø2 x 820 mmT602T6022020-08-26
07640187914092Handle for carbon offset reamer handleT18180T181802020-08-26
07640187917161Offset Cup Impactor 7/16-20 UNF Long = 3mmT18303T183032020-08-26
07640187910513Chisel handleT14584T145842020-08-25
07640187910520Slap hammerT14585T145852020-08-25
07640187910544Extraction clamp screwT17405T174052020-08-25
07640187911183IM reamer head dove tail Ø17 x 31 mm, can. Ø3.4 mmT3308T33082020-08-21
07640187911190IM reamer head dove tail Ø17.5 x 32 mm, can. Ø3.4 mmT3309T33092020-08-21
07640187911206IM reamer head dove tail Ø18 x 32 mm, can. Ø3.4 mmT3416T34162020-08-21
07640187911213IM reamer head dove tail Ø18.5 x 33 mm, can. Ø3.4 mmT3417T34172020-08-21
07640187911220IM reamer head dove tail Ø19 x 33 mm, can. Ø3.4 mmT3418T34182020-08-21
07640187911237IM reamer head dove tail Ø19.5 x 34 mm, can. Ø3.4 mmT3419T34192020-08-21
07640187911244IM reamer head dove tail Ø20 x 34 mm, can. Ø3.4 mmT3420T34202020-08-21
07640187911251IM reamer head dove tail Ø20.5 x 35 mm, can. Ø3.4 mmT10304T103042020-08-21
07640187911268IM reamer head dove tail Ø21 x 35 mm, can. Ø3.4 mmT3422T34222020-08-21
07640187911275IM reamer head dove tail Ø21.5 x 36 mm, can. Ø3.4 mmT10305T103052020-08-21

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