FDA.reportPublic FDA data

IM reamer head dove tail Ø9 x 21 mm, can. Ø3.4 mm

Primary DI
07640187918243
Brand
IM reamer head dove tail Ø9 x 21 mm, can. Ø3.4 mm
Company
MPS Micro Precision Systems AG
Model
T18830
Catalog number
T18830
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
07640187918243PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187918243076401879182437640187918243

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

Regulatory Flags#

DUNS number
482204059
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07640187918816Ortho Development Offset Cup Impactor, 5/16-24 UNF x 3.94T18928T189282026-09-27
07640187918809Straight reamer handleT18925T189252026-05-27
07640187918403TRIGEN MAX IM REAMER SHAFT 570 MM, HALL-JACOBST18771T187712026-02-24
07640187918410TRIGEN MAX ENTRY REAMER 12.5 MM, HALL-JACOBST18772T187722026-02-24
07640187917888TRIGEN MAX IM REAMER SHAFT 570 MM, JACOB-HALLT18771T187712025-01-22
07640187918069TRIGEN MAX ENTRY REAMER 12.5 MM, JACOB-HALLT18772T187722025-01-22
07640187917161Offset Cup Impactor 7/16-20 UNF Long = 3mmT18303T183032020-08-26
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
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

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