FDA.reportPublic FDA data

Arsenal Foot

Primary DI
00810028391765
Brand
Arsenal Foot
Company
Trilliant Surgical, LLC
Model
330-00-020
Device description
Arsenal Drill Tower Outer Sleeve
Published
2022-05-02
Public version status
Update
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
00810028391765PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391765008100283917658100283917650810028391765

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
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
00810028393431STAR PSI Tibia Cut Guide601-01-0002022-11-30
00810028393448STAR PSI Tibia Anatomical Model601-01-0012022-11-30
00810028393455STAR PSI Talus Cut Guide601-02-0002022-11-30
00810028393462STAR PSI Talus Anatomical Model601-02-0012022-11-30
00810028394971STAR PSI Standard Bundle with Anatomical Models601-00-0012022-11-30
0081292602720310mm Evans Plate300-54-2102017-03-15
0081292602721012mm Evans Plate300-54-2122017-03-15
00812926027791Tissue Retractor317-00-0072018-09-23
00812926027869Subtalar Implant System Sterilization Tray Lid112-99-0112018-09-23
0081292602851410 Hole Gridlock Helical Plate, Right300-65-0042018-10-15
00812926027036Tiger210-00-1022018-09-23
00812926027890Tiger210-99-1122018-09-23
00812926028002Gridlock320-99-1132018-09-23
00812926028026Gridlock310-00-0212018-09-23
00190446972020Generic Instrument215-00-0072026-07-16
00190446972037Generic Instrument215-00-0082026-07-16
00190446900498Arsenal Foot330-60-0072026-06-25
00190446900504Arsenal Foot330-60-0082026-06-25
00190446917861Arsenal Foot330-01-2152026-06-25
00190446917878Arsenal Foot330-01-2162026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776423896MillenniumAvalign Technologies, Inc.FZX2026-08-26
10886982362988NASynthes GmbHFZX2026-08-26
10886982362995NASynthes GmbHFZX2026-08-26
10886982363008NASynthes GmbHFZX2026-08-26
10886982363015NASynthes GmbHFZX2026-08-26
008890247114712.9 JuggerKnot Self-Punching ObturatorZimmer, Inc.FZX2026-08-25
008890247114882.9 JuggerKnot Self-Punching CannulaZimmer, Inc.FZX2026-08-25
00889024712294Pin Target AssemblyZimmer, Inc.FZX2026-08-25
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
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