Primary Device ID | 08033390140362 |
NIH Device Record Key | a6c43b41-206a-4f92-bc9b-5163dbd83a9d |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | TEMA Elbow |
Version Model Number | 1560.50.011 |
Catalog Number | 1560.50.011 |
Company DUNS | 432066322 |
Company Name | LIMACORPORATE SPA |
Device Count | 1 |
DM Exempt | false |
Pre-market Exempt | false |
MRI Safety Status | Labeling does not contain MRI Safety Information |
Human Cell/Tissue Product | false |
Device Kit | false |
Device Combination Product | false |
Single Use | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | false |
Expiration Date | true |
Donation Id Number | false |
Contains Natural Rubber Latex | false |
Labeled No Natural Rubber Latex | false |
RX Perscription | true |
OTC Over-The-Counter | false |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Size Text, specify | 0 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 08033390140362 [Primary] |
JDC | Prosthesis, Elbow, Constrained, Cemented |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2019-06-03 |
Device Publish Date | 2019-05-24 |
08033390148245 | Flexible Reamer Dia. 5.5 mm |
08033390148238 | Flexible Reamer Dia. 5 mm |
08033390148221 | Flexible Reamer Dia. 4.5 mm |
08033390147255 | Stem for Ulnar Liner Extraction |
08033390147248 | Guide for Ulnar Liner Extraction |
08033390147231 | Control Gauge for Implant Positioning – RIGHT |
08033390147224 | Control Gauge for Implant Positioning – LEFT |
08033390145695 | Humeral Press Adaptor |
08033390140362 | Ulnar Liner small right |
08033390140324 | Ulnar Stem U6.5 |
08033390140317 | Ulnar Stem U6 |
08033390140300 | Ulnar Stem U5.5 |
08033390140294 | Ulnar Liner large right |
08033390140287 | Humeral Body large right |
08033390140263 | Humeral Stem H10 right |
08033390140256 | Humeral Stem H9 right |
08033390140249 | Humeral Stem H9 left |
08033390140232 | Humeral Stem H8 right |
08033390140225 | Humeral Stem H8 left |
08033390140218 | Humeral Stem H7 right |
08033390140201 | Humeral Stem H7 left |
08033390140171 | Humeral Stem H6 right |
08033390140126 | Trial Ulnar Body + Liner Large - RIGHT |
08033390140119 | Trial Ulnar Body + Liner Small - RIGHT |
08033390140102 | Trial Ulnar Body + Liner Large - LEFT |
08033390140096 | Trial Ulnar Body + Liner Small - LEFT |
08033390140089 | Ulnar Body large right |
08033390140072 | Ulnar Body large left |
08033390140065 | Humeral Body small right |
08033390140058 | Ulnar Body small right |
08033390139335 | Ulnar Broach #U8 - RIGHT |
08033390139328 | Ulnar Broach #U8 - LEFT |
08033390139311 | Ulnar Broach #U7.5 - RIGHT |
08033390139304 | Ulnar Broach #U7.5 - LEFT |
08033390139298 | Distal Humeral Broach ##H11/12 - RIGHT |
08033390139281 | Distal Humeral Broach #H11/12 - LEFT |
08033390139274 | Proximal Humeral Broach #H12 |
08033390139267 | Proximal Humeral Broach #H11 |
08033390139250 | Stem for Humeral in Vivo Taper Assembler |
08033390139236 | Stem for Taper Breakers |
08033390139229 | Counter Torque for Axle Insertion |
08033390139212 | Slap Hammer |
08033390139205 | Ulnar Implant Extractor |
08033390139199 | Ulnar Implant Impactor |
08033390139144 | Ulnar Poly Bearing Press |
08033390139137 | Ulnar Stem Extractor |
08033390139120 | Axle Extractor |
08033390139113 | Ulnar Taper Breaker - RIGHT |
08033390139106 | Ulnar Taper Breaker - LEFT |
08033390139090 | Humeral Taper Breaker - RIGHT |