FDA.reportPublic FDA data

Broad Plate, 2.7T

Primary DI
10812269024232
Brand
Broad Plate, 2.7T
Company
MIAMI DEVICE SOLUTIONS LLC
Model
MDS1001B14
Catalog number
MDS1001B14
Device description
Broad Plate, 2.7T, 14 Holes
Published
2018-02-08
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10812269024232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1081226902423210812269024232

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

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
false
Premarket exempt
false
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
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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