FDA.reportPublic FDA data

16mm Concave Reamer Head

Primary DI
00812926023779
Brand
16mm Concave Reamer Head
Company
TRILLIANT SURGICAL, LTD.
Model
310-01-016
Published
2018-09-23
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
HTOReamer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926023779PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926023779008129260237798129260237790812926023779

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. 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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