Primary Device ID | 07630345708809 |
NIH Device Record Key | ae29b308-64b2-4a8d-9af5-a30773fd209c |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Shoulder - TiNbN Coating |
Version Model Number | 04.01.0258 |
Company DUNS | 488227125 |
Company Name | Medacta International SA |
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 Issuing Agency | Device ID |
---|---|
GS1 | 07630345708809 [Primary] |
KWS | Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer 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 | 2021-03-18 |
Device Publish Date | 2021-03-10 |
07630345709059 | SensiTiN Lat. Glenosphere 42xØ27 |
07630345709042 | SensiTiN Lat. Glenosphere 39xØ27 |
07630345709035 | SensiTiN Lat. Glenosphere 36xØ27 |
07630345709028 | SensiTiN Lat. Glenosphere 42xØ24.5 |
07630345709011 | SensiTiN Lat. Glenosphere 39xØ24.5 |
07630345709004 | SensiTiN Lat. Glenosphere 36xØ24.5 |
07630345708991 | SensiTiN Lat. Glenosphere 32xØ24.5 |
07630345708984 | SensiTiN Lat. Glenosphere 36xØ22 |
07630345708977 | SensiTiN Lat. Glenosphere 32xØ22 |
07630345708960 | SensiTiN Glenosphere 42xØ27 |
07630345708953 | SensiTiN Glenosphere 39xØ27 |
07630345708946 | SensiTiN Glenosphere 36xØ27 |
07630345708939 | SensiTiN Glenosphere 42xØ24.5 |
07630345708922 | SensiTiN Glenosphere 39xØ24.5 |
07630345708915 | SensiTiN Glenosphere 36xØ24.5 |
07630345708908 | SensiTiN Glenosphere 32xØ24.5 |
07630345708892 | SensiTiN Glenosphere 36xØ22 |
07630345708885 | SensiTiN Glenosphere 32xØ22 |
07630345708878 | SensiTiN Metal humeral head Ø58 |
07630345708861 | SensiTiN Metal humeral head Ø56 |
07630345708854 | SensiTiN Metal humeral head Ø54 |
07630345708847 | SensiTiN Metal humeral head Ø52 |
07630345708830 | SensiTiN Metal humeral head Ø50 |
07630345708823 | SensiTiN Metal humeral head Ø48 |
07630345708816 | SensiTiN Metal humeral head Ø46 |
07630345708809 | SensiTiN Metal humeral head Ø44 |
07630345708793 | SensiTiN Metal humeral head Ø42 |
07630345708786 | SensiTiN Metal humeral head Ø40 |