FDA.reportPublic FDA data

Torque Limiting Screwdriver Handle 3.5mm

Primary DI
07640187461459
Brand
Torque Limiting Screwdriver Handle 3.5mm
Company
Bonebridge AG
Model
B-420001
Published
2022-12-23
Public version status
Update
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
HXXScrewdriver

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXXScrewdriverOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07640187461459PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07640187461459076401874614597640187461459

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, 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, typically manual rotation of a bone screw or setscrew, whilst providing a torque-limiting function to ensure that the screw is not over tightened, during an orthopaedic procedure. The device is typically made of metal/synthetic material (e.g., polysulphone) and may have a T-shaped handle grip. It will normally provide an indication to the surgeon when the pre-set torque level is reached with an audible click and release of rotational traction. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
480244832
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
07640187463392POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, LeftB-2611002026-05-22
07640187463408POYA 3.5mm Medial Proximal Tibia Plate, 7 Hole, RightB-2621002026-05-22
07640187463415POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, LeftB-2612002026-05-22
07640187463422POYA 3.5mm Medial Proximal Tibia Plate, 10 Hole, RightB-2622002026-05-22
07640187463439POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, LeftB-2613002026-05-22
07640187463446POYA 3.5mm Medial Proximal Tibia Plate, 14 Hole, RightB-2623002026-05-22
07640187463460POYA Medial TemplateB-4200452026-05-22
07640187462760TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, LeftB-1214002026-01-16
07640187462777TAMINA 3.5mm Proximal Humerus Plate, 7 Hole, Long, RightB-1224002026-01-16
07640187463125Lag Screw Drill Guide 2.5mmB-4100192026-01-16
07640187463132Drill Bit Ø2.5mm x 140mmB-4200442026-01-16
07640187463149Bending Iron SmallB-4100212026-01-16
07640187463156Bending Plier SmallB-4100222026-01-16
07640187463163Cutting PlierB-4100232026-01-16
07640187463101Monoaxial Drill Guide 2.5mmB-4100172026-01-15
07640187463118Insert Monoaxial Drill Guide 2.5mmB-4100182026-01-15
07640187463187BRUSIO 2.5mm Reinforced Straight Plate, 6 HoleB-1710062026-01-15
07640187463194BRUSIO 2.5mm Reinforced Straight Plate, 10 HoleB-1710102026-01-15
07640187463200BRUSIO 2.5mm Reinforced Straight Plate, 14 HoleB-1710142026-01-15
07640187463217BRUSIO 2.5mm Reinforced Straight Plate, 18 HoleB-1710182026-01-15

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