Geminus XL GMN-LTN-160

GUDID 00841506107486

Assembled, Geminus Volar Distal Radius Plate, Narrow, 160mm, Left

SKELETAL DYNAMICS L.L.C.

Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterile
Primary Device ID00841506107486
NIH Device Record Key2957ebec-da01-4cbe-9867-e9eb67dc45eb
Commercial Distribution StatusIn Commercial Distribution
Brand NameGeminus XL
Version Model NumberAssembled, Geminus, Narrow, 160mm, Left
Catalog NumberGMN-LTN-160
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100841506107486 [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 Date2019-06-21
Device Publish Date2019-06-13

On-Brand Devices [Geminus XL]

00841506109961GEMINUS XL Volar Distal Radius Plate System
00841506109176GEMINUS Volar Distal Plate System Long Plate Module
00841506109121Tissue Protector/Drill Guide, Slot, 2.5mm
00841506107509Assembled, Geminus Volar Distal Radius Plate, Narrow, 200mm, Left
00841506107493Assembled, Geminus Volar Distal Radius Plate, Narrow, 200mm, Right
00841506107486Assembled, Geminus Volar Distal Radius Plate, Narrow, 160mm, Left
00841506107479Assembled, Geminus Volar Distal Radius Plate, Narrow, 160mm, Right
00841506107462Assembled, Geminus Volar Distal Radius Plate, Narrow, 120mm, Left
00841506107455Assembled, Geminus Volar Distal Radius Plate, Narrow, 120mm, Right
00841506107448Geminus Volar Distal Radius Plate, Narrow, 200mm, Left
00841506107431Geminus Volar Distal Radius Plate, Narrow, 200mm, Right
00841506107424Geminus Volar Distal Radius Plate, Narrow, 165mm, Left
00841506107417Geminus Volar Distal Radius Plate, Narrow, 165mm, Right
00841506107400Geminus Volar Distal Radius Plate, Narrow, 125mm, Left
00841506107394Geminus Volar Distal Radius Plate, Narrow, 125mm, Right
00841506107387Geminus Volar Distal Radius Plate, Standard, 200mm, Left
00841506107370Geminus Volar Distal Radius Plate, Standard, 200mm, Right
00841506107363Geminus Volar Distal Radius Plate, Standard, 165mm, Left

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