Forearm Plating System UNV-BND-35

GUDID 00841506110011

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00841506110011
NIH Device Record Key0052b4df-c9bc-4adc-a1b3-f2b803a49b90
Commercial Distribution StatusIn Commercial Distribution
Brand NameForearm Plating System
Version Model NumberUniversal Bending Irons, 3.5mm
Catalog NumberUNV-BND-35
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 Usefalse
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506110011 [Primary]

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 [Forearm Plating System]

00841506115887FreeFix Depth Gage
00841506115740FreeFix Midshaft Radius Plate, 188mm
00841506115399FreeFix Midshaft Ulna Plate, 157mm
00841506115382FreeFix Midshaft Ulna Plate, 127mm
00841506115375FreeFix Midshaft Ulna Plate, 112mm
00841506114590FreeFix Midshaft Radius Plate, 142mm
00841506114583FreeFix Midshaft Radius Plate, 112mm
00841506114576FreeFix Midshaft Radius Plate, 81mm
00841506113012FreeFix Midshaft Radius Plate, 157mm
00841506112992FreeFix Midshaft Radius Plate, 97mm
00841506112732Drill Guide, FreeFix™, 2.7mm
00841506110011Universal Bending Irons, 3.5mm
00841506109978Forceps, Bone Holding Medium, Long Ratcheting
00841506108858Drill, Solid Side Cutting, 2.5mm x 40mm (OUS)

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