FDA.reportPublic FDA data

2.7mm Arsenal Drill Sleeves

Primary DI
00812926029771
Brand
2.7mm Arsenal Drill Sleeves
Company
TRILLIANT SURGICAL, LTD.
Model
330-27-006
Published
2019-10-01
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

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
00812926029771PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926029771008129260297718129260297710812926029771

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
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
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810028391512Arsenal Petite MPJ Plate, L, 0°300-82-0072021-09-03
00810028391529Arsenal Petite MPJ Plate, R, 0°300-82-0082021-09-03
00810028391536Arsenal Petite MPJ Plate, L, 5°300-82-0092021-09-03
00810028391543Arsenal Petite MPJ Plate, R, 5°300-82-0102021-09-03
00810028391550Arsenal Short 5th Met Hook Plate, L300-84-0032021-09-03
00810028391567Arsenal Short 5th Met Hook Plate, R300-84-0042021-09-03
00810028391574Arsenal U-Plate, Small, L300-85-0052021-09-03
00810028391581Arsenal U-Plate, Small, R300-85-0062021-09-03
00810028391598Arsenal U-Plate, Standard, L300-85-0072021-09-03
00810028391604Arsenal U-Plate, Standard, R300-85-0082021-09-03
00810028391420Arsenal Modular Tray Lid330-01-2012021-06-28
00810028391437Arsenal Modular Tray Sublevel330-01-2022021-06-28
00810028391444Arsenal 2.7mm/3.5mm Screw Module330-01-2032021-06-28
00810028391451Arsenal Modular Caddy Base330-01-2042021-06-28
00810028391468Arsenal Modular Caddy Lid330-01-2052021-06-28
00810028391475Arsenal MPJ Plating Caddy330-01-2062021-06-28
00810028391482Arsenal Reamer Caddy330-01-2072021-06-28
00810028391499Arsenal Lapidus Plating Caddy330-01-2082021-06-28
00810028391505Arsenal Universal Plating Caddy330-01-2092021-06-28
00812926029917K-Wire Tube330-01-2102021-06-28

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Primary DI, Brand, Company table
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03662663143493MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143509MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143516MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143523MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
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00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
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10705034578873N/AMedos International SàrlFZX2026-03-05
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09421038411940Dist Fem Cut Block Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411957Dist Fem Cut Block Slot Connector – 8mmENZTEC LIMITEDFZX2026-02-27
09421038411964Dist Fem Cut Block Slot Connector – 9mmENZTEC LIMITEDFZX2026-02-27
09421038411971Dist Fem Cut Block Slot Connector – 10mmENZTEC LIMITEDFZX2026-02-27
09421038411988Dist Fem Cut Block – 1.27mmENZTEC LIMITEDFZX2026-02-27
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