FDA.reportPublic FDA data

Low Profile Head Screw, 2.7mm

Primary DI
10812269023501
Brand
Low Profile Head Screw, 2.7mm
Company
MIAMI DEVICE SOLUTIONS LLC
Model
MDS1002CO34
Catalog number
MDS1002CO34
Device description
Low Profile Head Screw, Ø2.7mm x L34mm
Published
2018-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
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
10812269023501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081226902350110812269023501

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length34Millimeter
Outer Diameter2.7Millimeter

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
DM exempt
true
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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