TEMA Elbow 1552.14.020

GUDID 08033390140072

Ulnar Body large left

LIMACORPORATE SPA

Metal-backed elbow ulna prosthesis
Primary Device ID08033390140072
NIH Device Record Keyfec869a0-a456-41ae-ba4a-7744ce6492ec
Commercial Distribution StatusIn Commercial Distribution
Brand NameTEMA Elbow
Version Model Number1552.14.020
Catalog Number1552.14.020
Company DUNS432066322
Company NameLIMACORPORATE SPA
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 Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS108033390140072 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JDBProsthesis, Elbow, Semi-Constrained, Cemented

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-06-03
Device Publish Date2019-05-24

On-Brand Devices [TEMA Elbow]

08033390148245Flexible Reamer Dia. 5.5 mm
08033390148238Flexible Reamer Dia. 5 mm
08033390148221Flexible Reamer Dia. 4.5 mm
08033390147255Stem for Ulnar Liner Extraction
08033390147248Guide for Ulnar Liner Extraction
08033390147231Control Gauge for Implant Positioning – RIGHT
08033390147224Control Gauge for Implant Positioning – LEFT
08033390145695Humeral Press Adaptor
08033390140362Ulnar Liner small right
08033390140324Ulnar Stem U6.5
08033390140317Ulnar Stem U6
08033390140300Ulnar Stem U5.5
08033390140294Ulnar Liner large right
08033390140287Humeral Body large right
08033390140263Humeral Stem H10 right
08033390140256Humeral Stem H9 right
08033390140249Humeral Stem H9 left
08033390140232Humeral Stem H8 right
08033390140225Humeral Stem H8 left
08033390140218Humeral Stem H7 right
08033390140201Humeral Stem H7 left
08033390140171Humeral Stem H6 right
08033390140126Trial Ulnar Body + Liner Large - RIGHT
08033390140119Trial Ulnar Body + Liner Small - RIGHT
08033390140102Trial Ulnar Body + Liner Large - LEFT
08033390140096Trial Ulnar Body + Liner Small - LEFT
08033390140089Ulnar Body large right
08033390140072Ulnar Body large left
08033390140065Humeral Body small right
08033390140058Ulnar Body small right
08033390139335Ulnar Broach #U8 - RIGHT
08033390139328Ulnar Broach #U8 - LEFT
08033390139311Ulnar Broach #U7.5 - RIGHT
08033390139304Ulnar Broach #U7.5 - LEFT
08033390139298Distal Humeral Broach ##H11/12 - RIGHT
08033390139281Distal Humeral Broach #H11/12 - LEFT
08033390139274Proximal Humeral Broach #H12
08033390139267Proximal Humeral Broach #H11
08033390139250Stem for Humeral in Vivo Taper Assembler
08033390139236Stem for Taper Breakers
08033390139229Counter Torque for Axle Insertion
08033390139212Slap Hammer
08033390139205Ulnar Implant Extractor
08033390139199Ulnar Implant Impactor
08033390139144Ulnar Poly Bearing Press
08033390139137Ulnar Stem Extractor
08033390139120Axle Extractor
08033390139113Ulnar Taper Breaker - RIGHT
08033390139106Ulnar Taper Breaker - LEFT
08033390139090Humeral Taper Breaker - RIGHT

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