FDA.reportPublic FDA data

Torque Limiter T-Handle

Primary DI
10812269020012
Brand
Torque Limiter T-Handle
Company
MIAMI DEVICE SOLUTIONS LLC
Model
MDS000602AOT
Catalog number
MDS000602AOT
Device description
Torque Limiter T-Handle, AO, 3Nm, Green
Published
2017-01-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812269020012PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081226902001210812269020012

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument torque limiterA small device designed to attach to a surgical power tool (e.g., the proximal end of a surgical drill handpiece) or a manual surgical instrument (e.g., a screwdriver) to define the torque effect of that tool allowing the surgeon to apply the correct torque, e.g., when tightening an orthopaedic fixation screw during a surgical intervention. It is typically made of high-grade stainless steel or synthetic materials and includes a built-in clutch mechanism. It is available in various shapes, sizes and torque ranges. 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

Contacts#

Phone, Email table
PhoneEmail
(786) 422-1400customerservice@miamidevicesolutions.com

Regulatory Flags#

DUNS number
078703080
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10812269021804Distal Radius PlateMDS14010601MDS140106012016-09-20
10812269021811Distal Radius PlateMDS14010602MDS140106022016-09-20
10812269022603Distal Radius PlateMDS14010503MDS140105032016-09-20
10812269022610Distal Radius PlateMDS14010603MDS140106032016-09-20
10812269022665Olecranon Plate, 4 Hole, Left MDS160104LMDS160104L2017-10-09
10812269022818Olecranon Plate, 2 Hole, LeftMDS160102LMDS160102L2017-10-10
10812269022825Olecranon Plate, 2 Hole, RightMDS160102RMDS160102R2017-10-09
10812269022832Olecranon Plate, 4 Hole, RightMDS160104RMDS160104R2017-10-09
10812269023662Extra Articular Distal Humerus Plate MDS170104LMDS170104L2018-01-02
10812269023679Extra Articular Distal Humerus PlateMDS170106LMDS170106L2018-01-02
10812269023686Extra Articular Distal Humerus Plate MDS170108LMDS170108L2018-01-02
10812269023693Extra Articular Distal Humerus Plate MDS170110LMDS170110L2018-01-02
10812269023709Extra Articular Distal Humerus PlateMDS170112LMDS170112L2018-01-02
10812269023716Extra Articular Distal Humerus PlateMDS170114LMDS170114L2018-01-02
10812269023723Extra Articular Distal Humerus PlateMDS170104RMDS170104R2018-01-02
10812269023730Extra Articular Distal Humerus PlateMDS170106RMDS170106R2018-01-02
10812269023747Extra Articular Distal Humerus PlateMDS170108RMDS170108R2018-01-02
10812269023754Extra Articular Distal Humerus PlateMDS170110RMDS170110R2018-01-02
10812269023761Extra Articular Distal Humerus PlateMDS170112RMDS170112R2018-01-02
10812269023778Extra Articular Distal Humerus PlateMDS170114RMDS170114R2018-01-02

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