Primary Device ID | 07630345710369 |
NIH Device Record Key | 35fb2734-4fde-4b71-b1e5-d33015aaf471 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Glenoid Reconstruction System |
Version Model Number | 04.01.0307 |
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 | 07630345710369 [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 | 2022-12-06 |
Device Publish Date | 2022-11-28 |
07630345710529 | GRS central screw - L30 |
07630345710512 | GRS central screw - L25 |
07630345710505 | GRS central screw - L20 |
07630345710499 | GRS central screw - L15 |
07630345710406 | GRS baseplate - Ø27x30 +6mm |
07630345710390 | GRS baseplate - Ø27x30 +3mm |
07630345710383 | GRS baseplate - Ø27x30 |
07630345710376 | GRS baseplate - Ø27x20 +6mm |
07630345710369 | GRS baseplate - Ø27x20 +3mm |
07630345710352 | GRS baseplate - Ø27x20 |
07630345710345 | GRS baseplate - Ø24.5x30 +6mm |
07630345710338 | GRS baseplate - Ø24.5x30 +3mm |
07630345710321 | GRS baseplate - Ø24.5x30 |
07630345710314 | GRS baseplate - Ø24.5x20 +6mm |
07630345710307 | GRS baseplate - Ø24.5x20 +3mm |
07630345710291 | GRS baseplate - Ø24.5x20 |