FDA.reportPublic FDA data

Screwdriver Bit Torx

Primary DI
G28433301
Brand
Screwdriver Bit Torx
Company
Neurovention LLC
Model
333-01
Device description
Screwdriver Bit T4 Torx, Single Use
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HAOInstrument, Surgical, Non-Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G28433301PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, single-use, non-sterileA non-sterile, non-powered tool that fits into a screw head in order to apply rotation to tighten/loosen/remove a screw during a surgical procedure. It typically has a high-grade stainless steel shaft with a distal end dedicated to fit into a screw head that may be slotted, Phillips (cross head), Pozidriv (Supadriv), Torx, Hex (Allen), Robertson (square), spanner head (twin pins), Polydrive, or one-way (clutch). The proximal end of the shaft may have a handle for manual use, or it may have a profiled tang that fits into an interchangeable screwdriver handle, a manually-operated chuck, or a power driver. This is a single-use device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
074912476
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G28424104Screw T6 Torx241-042025-05-12
G28433305Screwdriver Bit Torx333-052025-05-12
G2843520100Drill Bit352-01-002024-10-17
G284241019Screw Torx Slot241-012022-09-09
G28424101Screw Torx Slot241-012022-06-21
G28435101Rescue Screw Torx Slot351-012022-06-21
G284NN01TrayNN-012022-06-21
G28433302Screwdriver Bit Torx Slot333-022022-06-22
G28433001NuCrani Small Plate330-012022-06-21
G28435201Drill Bit352-012022-06-21
G28435301Screwdriver353-012022-06-21
G28436102NuCrani Large Plate361-022022-06-21
G28437801Screwdriver Spanner378-012022-06-21
G28440901KTC Burr Hole Cover409-012022-06-21
G28441001KTC Burr Hole Cover410-012022-06-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G586N93065370Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G586N93065380Novo SurgicalNOVO SURGICAL, INC.HAO2024-02-22
G28435301ScrewdriverNeurovention LLCHAO2022-06-21
07613327262322XIAStryker CorporationHAO2019-11-21
07613327264432XIA 4.5Stryker CorporationHAO2019-11-21
07613327264951XIA 3Stryker CorporationHAO2019-11-21
07613327271447OASYSStryker CorporationHAO2019-11-21
07613327276176RADIUSStryker CorporationHAO2019-11-21
07613327263787RELIANCE LITeStryker CorporationHAO2019-11-20
07613327263923RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265897RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265910RELIANCE LITeStryker CorporationHAO2019-11-20
07613327265934RELIANCE LITeStryker CorporationHAO2019-11-20
07613327266016RELIANCE LITeStryker CorporationHAO2019-11-20
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