Proximal Ulna Plate PUPF-5SR

GUDID 00841506134383

SKELETAL DYNAMICS L.L.C.

Orthopaedic fixation plate, non-bioabsorbable
Primary Device ID00841506134383
NIH Device Record Key47605463-fb9e-4b1a-bc93-9f04416cdb76
Commercial Distribution StatusIn Commercial Distribution
Brand NameProximal Ulna Plate
Version Model NumberFreeFix, Proximal Ulna Plate, 5 Slot, Right
Catalog NumberPUPF-5SR
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506134383 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HRSPlate, fixation, bone

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


[00841506134383]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-29
Device Publish Date2023-12-21

On-Brand Devices [Proximal Ulna Plate]

00841506134918PUP Extension, 2 Hole
00841506134901PUP Extension, 1 Hole
00841506134437FreeFix, Proximal Ulna Plate, 6 Slot, Left
00841506134420FreeFix, Proximal Ulna Plate, 6 Slot, Right
00841506134413FreeFix, Proximal Ulna Plate, 5 Slot Plus, Left
00841506134406FreeFix, Proximal Ulna Plate, 5 Slot Plus, Right
00841506134390FreeFix, Proximal Ulna Plate, 5 Slot, Left
00841506134383FreeFix, Proximal Ulna Plate, 5 Slot, Right
00841506134376FreeFix, Proximal Ulna Plate, 4 Slot, Left
00841506134369FreeFix, Proximal Ulna Plate, 4 Slot, Right
00841506134352FreeFix, Proximal Ulna Plate, 3 Slot, Left
00841506134345FreeFix, Proximal Ulna Plate, 3 Slot, Right
00841506134321FreeFix, Proximal Ulna Plate, 2 Slot, Right
00841506134215Drill Guide, FreeFix™, PUP
00841506131917Proximal Ulna Plating System, Sterilization Tray,
00841506131900Proximal Ulna Plating System, Sterilization Tray,
00841506131894Proximal Ulna Plating System, Sterilization Tray,
00841506131887Proximal Ulna Plating System, Sterilization Tray,
00841506131870Proximal Ulna Plating System, Sterilization Tray,
00841506131689Proximal Ulna Plating System, Sterilization Tray (
00841506130224Screw, FreeFix™ Compression, 3.5mm x 08mm, Ti
00841506129990Screw, FreeFix Locking, 3.5mm x 08mm, Ti
00841506115719Drill, 3.5mm x 70mm, Reusable
00841506134338FreeFix, Proximal Ulna Plate, 2 Slot, Left
00841506131986Proximal Ulna Plating System

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