Primary Device ID | 03701037315408 |
NIH Device Record Key | 1f0da8ef-e183-4dbc-a4a1-dad4fc12c1cb |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | FX V135 Shoulder Prosthesis |
Version Model Number | 203-0906 |
Company DUNS | 263076196 |
Company Name | FX SOLUTIONS |
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 | 03701037315408 [Primary] |
PHX | Shoulder Prosthesis, Reverse Configuration |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-01-30 |
Device Publish Date | 2024-01-22 |
03701037315408 | 203-0906 FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +6 |
03701037315392 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +3 |
03701037315385 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +9 |
03701037315378 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +6 |
03701037315361 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø32 +3 |
03701037315323 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +9 |
03701037315316 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +6 |
03701037315309 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3 |
03701037315293 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +9 |
03701037315286 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +6 |
03701037315279 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø32 +3 |
03701037317174 | OFFSET HEAD 50x22 |
03701037317167 | OFFSET HEAD 50x18 |
03701037317150 | CENTERED HEAD 50x21 |
03701037317143 | CENTERED HEAD 50x17 |
03701037317136 | OFFSET HEAD 48x21 |
03701037317129 | OFFSET HEAD 48x17 |
03701037317112 | CENTERED HEAD 48x20 |
03701037317105 | CENTERED HEAD 48x16 |
03701037317099 | OFFSET HEAD 46x20 |
03701037317082 | OFFSET HEAD 46x16 |
03701037317075 | CENTERED HEAD 46x19 |
03701037317068 | CENTERED HEAD 46x15 |
03701037317051 | OFFSET HEAD 43x19 |
03701037317044 | OFFSET HEAD 43x15 |
03701037317037 | CENTERED HEAD 43x18 |
03701037317020 | CENTERED HEAD 43x14 |
03701037317013 | OFFSET HEAD 41x18 |
03701037317006 | OFFSET HEAD 41x14 |
03701037316993 | CENTERED HEAD 41x17 |
03701037316986 | CENTERED HEAD 41x13 |
03701037316979 | OFFSET HEAD 39x17 |
03701037316962 | OFFSET HEAD 39x13 |
03701037316955 | CENTERED HEAD 39x16 |
03701037316948 | CENTERED HEAD 39x13 |
03701037315446 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9 |
03701037315439 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6 |
03701037315422 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +3 |
03701037315415 | FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø36 +9 |
03701037315354 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +9 |
03701037315347 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +6 |
03701037315330 | FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3 |
03701037320396 | Glenoid Manual Reamer Ø36mm |
03701037320389 | Glenoid Manual Reamer Ø40mm |