Humeral Plating System SCL-196

GUDID 00841506110295

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00841506110295
NIH Device Record Key2fd71143-1422-411f-a461-021603bc3a42
Commercial Distribution StatusIn Commercial Distribution
Brand NameHumeral Plating System
Version Model NumberDistal Humerus Plate, Supracondylar, 196mm, Left
Catalog NumberSCL-196
Company DUNS869056148
Company NameSKELETAL DYNAMICS L.L.C.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com
Phone+1(305)596-7585
Emailfeedback@skeletaldynamics.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506110295 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-12-03
Device Publish Date2020-11-25

On-Brand Devices [Humeral Plating System]

00841506116303Humeral Plating Set Tray A
00841506115894Depth Gauge, MT, 80mm
00841506115818Countersink, 6.5mm
00841506115801Drill, 3.2mm / 4.5mm
00841506115764Thread-In Drill Guide, FreeFix, 4.5mm
00841506115696Distal Trochlea Compression Screw, 3.5mm x 80mm, T
00841506115689Distal Trochlea Compression Screw, 3.5mm x 75mm, T
00841506115672Distal Trochlea Compression Screw, 3.5mm x 70mm, T
00841506115665Distal Trochlea Compression Screw, 3.5mm x 65mm, T
00841506115641Distal Trochlea Compression Screw, 3.5mm x 55mm, T
00841506115634Distal Trochlea Compression Screw, 3.5mm x 50mm, T
00841506115610Distal Trochlea Compression Screw, 3.5mm x 40mm, T
00841506114989Drill, 2.0mm x 80mm
00841506114842Hohmann Retractor, Large
00841506114811Bending Rod, DHP
00841506114729K-Wire, Single Trocar, 1.5 mm x 229 mm
00841506114699Universal Bending Irons, 4.5mm
00841506112527Distal Humerus Plate, Lateral Direct, 175mm, Left
00841506112510Distal Humerus Plate, Lateral Direct, 175mm, Right
00841506112503Distal Humerus Plate, Lateral Direct, 145mm, Left
00841506112480Distal Humerus Plate, Lateral Direct, 115mm, Left
00841506112435Drill, Cannulated, 3.7mm x 80mm
00841506111544Midshaft Humerus Plate, Narrow 244mm
00841506111537Midshaft Humerus Plate, Narrow 208mm
00841506111520Midshaft Humerus Plate, Narrow 172mm
00841506111513Midshaft Humerus Plate, Narrow 136mm
00841506111506Midshaft Humerus Plate, Broad 244mm
00841506111483Midshaft Humerus Plate, Broad 172mm
00841506111469Drill Guide, FreeFix™, HPS
00841506111445Driver, Universal, T15
00841506111407Screw, Compression, 4.5mm x 34mm, Ti
00841506111391Screw, Compression, 4.5mm x 32mm, Ti
00841506111384Screw, Compression, 4.5mm x 30mm, Ti
00841506111377Screw, Compression, 4.5mm x 28mm, Ti
00841506111360Screw, Compression, 4.5mm x 26mm, Ti
00841506111353Screw, Compression, 4.5mm x 24mm, Ti
00841506111339Screw, Compression, 4.5mm x 20mm, Ti
00841506111322Screw, Compression, 4.5mm x 18mm, Ti
00841506111315Screw, Compression, 4.5mm x 16mm, Ti
00841506111308Screw, Compression, 4.5mm x 14mm, Ti
00841506111230Screw, Locking, FreeFix, 4.5mm x 34mm, Ti
00841506111223Screw, Locking, FreeFix, 4.5mm x 32mm, Ti
00841506111216Screw, Locking, FreeFix, 4.5mm x 30mm, Ti
00841506111209Screw, Locking, FreeFix, 4.5mm x 28mm, Ti
00841506111193Screw, Locking, FreeFix, 4.5mm x 26mm, Ti
00841506111186Screw, Locking, FreeFix, 4.5mm x 24mm, Ti
00841506111179Screw, Locking, FreeFix, 4.5mm x 22mm, Ti
00841506111162Screw, Locking, FreeFix, 4.5mm x 20mm, Ti
00841506111155Screw, Locking, FreeFix, 4.5mm x 18mm, Ti
00841506111148Screw, Locking, FreeFix, 4.5mm x 16mm, Ti
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