FDA.report

2.7mm Arsenal Ankle Drill Sleeves

Primary DI
00810028391802
Brand
2.7mm Arsenal Ankle Drill Sleeves
Company
Trilliant Surgical, LLC
Model
340-27-006
Published
2022-05-02
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

Related Records

Product Codes

CodeName
FZXGuide, Surgical, Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810028391802PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391802008100283918028100283918020810028391802

GMDN Terms

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
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 DIBrandModelCatalogPublished
00190446898801Arsenal Foot330-60-0062026-03-19
00190446898757Stabilization330-27-0032025-07-01
00190446898764Stabilization330-27-0132025-07-01
00190446898771Stabilization330-35-0132025-07-01
00190446898795Stabilization330-00-0112025-07-01
00190446898818Stabilization330-27-0162025-07-01
00190446898825Stabilization330-35-0162025-07-01
00190446898832Stabilization330-00-0172025-07-01
00190446910091Stabilization330-01-3012025-07-01
00190446910459Stabilization330-01-3022025-07-01
00190446910466Stabilization330-01-3032025-07-01
00190446910473Stabilization330-01-3042025-07-01
00190446910480Stabilization330-01-3052025-07-01
00190446910497Stabilization330-01-3072025-07-01
00190446910503Stabilization330-01-3082025-07-01
00810028395800Arsenal Reloaded330-01-2142025-04-03
00810028395817Arsenal Reloaded330-01-2122025-04-03
00810028395824Arsenal Reloaded 330-01-2112025-04-03
00810028395831Arsenal Reloaded 330-01-2132025-04-03
00190446898269Stabilization340-01-2072024-12-18

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