UNI-ELBOW 410-0001

GUDID 00886385025940

Radio Capitellum Small, Left

Stryker Trauma SA

Uncoated elbow humerus prosthesis Uncoated elbow humerus prosthesis
Primary Device ID00886385025940
NIH Device Record Key68dda653-2a1b-42bd-912a-9043cfe8d081
Commercial Distribution StatusIn Commercial Distribution
Brand NameUNI-ELBOW
Version Model Number410-0001
Catalog Number410-0001
Company DUNS481999654
Company NameStryker Trauma SA
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100886385025940 [Primary]

FDA Product Code

JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2015-09-24

On-Brand Devices [UNI-ELBOW]

00886385026473Radio Capitellum Instrument Tray Lid Uni-Elbow
00886385026466Radio Capitellum Instrument Tray
00886385026459Axis Locator Clamp, Drill Guide
00886385026442Axis Locator Clamp, Upper Arm
00886385026435Axis Locator Clamp, Cup Position Bolt
00886385026428Axis Locator Clamp, Location Cup
00886385026411Axis Locator Clamp, Slot Position Bolt
00886385026404Axis Locator Clamp, L-Bar
00886385026374Resection Guide, Handle
00886385026367Radio Capitellum, Resection Guide, LG
00886385026350Radio Capitellum, Resection Guide, SM
00886385026299Radio Capitellum, Impactor Assembly
00886385026268Radio Capitellum, Broach Right, LG
00886385026237Radio Capitellum, Broach Right, SM
00886385026206Radio Capitellum, Broach Left, LG
00886385026176Radio Capitellum, Broach Left, SM
00886385026145Radio Capitellum, Trial, Right, LG
00886385026138Radio Capitellum, Trial, Right, SM
00886385026121Radio Capitellum, Trial, Left LG
00886385026114Radio Capitellum, Trial, Left SM
00886385026091Radio Capitellum, Template, LG
00886385026077Radio Capitellum, Template, SM
00886385026060Radio Capitellum, Trial, Handle Uni-Elbow
00886385026022Radio Capitellum, Recon Head, Size #4
00886385026015Radio Capitellum, Recon Head, Size #3
00886385026008Radio Capitellum, Recon Head, Size #2
00886385025995Radial Head Assy Size 4, Rad
00886385025988Radial Head Assy Size 3, Rad
00886385025971Radial Head Assy Size 2, Rad
00886385025964Radio Capitellum Small, Right
00886385025957Radio Capitellum Large, Right
00886385025940Radio Capitellum Small, Left
00886385025933Radio Capitellum Large, Left

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