FDA.reportPublic FDA data

Screwdriver

Primary DI
G28435301
Brand
Screwdriver
Company
Neurovention LLC
Model
353-01
Device description
Screwdriver
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXLScrewdriver, SkullplateNeurology1
HAOInstrument, Surgical, Non-PoweredNeurology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G28435301PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

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
G28433301Screwdriver Bit Torx333-012022-06-21
G28435201Drill Bit352-012022-06-21
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

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