FDA.reportPublic FDA data

Arsenal Screw Remover

Primary DI
00810028391338
Brand
Arsenal Screw Remover
Company
TRILLIANT SURGICAL, LTD.
Model
330-00-009
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
HWBExtractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWBExtractorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028391338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391338008100283913388100283913380810028391338

GMDN Terms#

Term, Definition table
TermDefinition
Screw extractor, reusableA hand-held manual surgical tool designed to remove implanted screws that have a damaged screw recess by self-tapping into the defective recess/head and providing sufficient grip to rotate and remove the screw in the normal way. It typically has a conical tip. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885862648143EquinoxeExactech, Inc.HWB2026-03-19
10885862660466N/AExactech, Inc.HWB2026-03-19
10885862663214N/AExactech, Inc.HWB2026-03-19
B922F00500380ACURA Stabilization SystemINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITEDHWB2026-03-11
00841435122574TecometTECOMET INC.HWB2026-02-27
07899258695174Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695181Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695198Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695204Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695211Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695228Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
07899258695235Screw Removal KitGM DOS REIS INDUSTRIA E COMERCIO LTDAHWB2026-02-20
03662663131759Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWB2026-02-11
00840338602497Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338602961Made-To-OrderTORNIER, INC.HWB2026-02-03
00840338607799Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00840338607805Tornier Perform Reversed MonoPost GlenoidTORNIER, INC.HWB2026-01-21
00889024704008LB Type 1 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704015LZ 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704022LB 12/14 Taper Extraction InsertZimmer, Inc.HWB2025-12-18
00889024704039Fitmore Extraction Adapter - MZimmer, Inc.HWB2025-12-18
00889024704046Fitmore Extraction Adapter - FZimmer, Inc.HWB2025-12-18
03662663274128Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-18
03662663217415Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217439Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217446Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217453Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663217460Vail OCT Spinal Fixation SystemHighridge Medical, LLCHWB2025-12-17
03662663279277Timberline Lateral Fusion SystemHighridge Medical, LLCHWB2025-12-16
10603295505044ATTUNEDEPUY (IRELAND)HWB2025-12-11