FDA.reportPublic FDA data

3S Hemi Handle

Primary DI
00812926020129
Brand
3S Hemi Handle
Company
TRILLIANT SURGICAL, LTD.
Model
111-00-002
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
HWAImpactor
MDMInstrument, Manual, Surgical, General Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1
MDMInstrument, Manual, Surgical, General UseGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812926020129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812926020129008129260201298129260201290812926020129

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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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