FDA.reportPublic FDA data

Straight guide Ø2 x 820 mm

Primary DI
07640187918168
Brand
Straight guide Ø2 x 820 mm
Company
MPS Micro Precision Systems AG
Model
T18822
Catalog number
T18822
Published
2025-05-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187918168PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187918168076401879181687640187918168

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated/tubular orthopaedic implant (typically an intramedullary nail, a bone screw or femoral fixation plate) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

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Primary DI, Brand, Company table
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03701089543316AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543330AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543354AMPLITUDEAMPLITUDE SASFZX2026-07-29
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