| Primary Device ID | 00885556812815 |
| NIH Device Record Key | 77c5fff7-6ed6-4478-98de-d13976e00ef2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AETOS Shoulder System |
| Version Model Number | DRG0990-825-205FR |
| Catalog Number | DRG0990-825-205FR |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Special Storage Condition, Specify | Between 0 and 0 *: - |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556812815 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
[00885556812815]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-15 |
| Device Publish Date | 2023-02-07 |
| 00885556810941 | 42MM REVERSE LINER PLS 9 LRG RETENTIVE |
| 00885556813331 | REVERSE INSTRUMENT TRAY SCREW CADDY |
| 00885556813324 | REVERSE INSTRUMENT TRAY INSERT ASSEMBLY |
| 00885556813317 | REVERSE INSTRUMENT TRAY BASE ASSEMBLY |
| 00885556813300 | GENERAL INSTRUMENT TRAY ASSEMBLY |
| 00885556813294 | GENERAL INSTRUMENT TRAY BASE ASSEMBLY |
| 00885556811962 | STEM COMPACTOR SIZE 5 |
| 00885556811955 | STEM COMPACTOR SIZE 4 |
| 00885556811948 | STEM COMPACTOR SIZE 3 |
| 00885556811931 | STEM COMPACTOR SIZE 2 |
| 00885556811924 | STEM COMPACTOR SIZE 1 |
| 00885556813379 | ANATOMIC INSTRUMENT TRAY INSTRUMENT CADDY |
| 00885556813362 | ANATOMIC INSTRUMENT TRAY 4 PEG INSERT ASSEMBLY |
| 00885556813355 | ANATOMIC INSTRUMENT TRAY BASE ASSEMBLY |
| 00885556813348 | REVERSE INSTRUMENT TRAY SCREW CADDY LID |
| 00885556871362 | CUT PROTECTOR LARGE |
| 00885556813393 | GENERIC INSTRUMENT TRAY LID |
| 00885556813386 | ANATOMIC INSTRUMENT TRAY INSTRUMENT CADDY LID |
| 00885556812853 | GLENOID DRL GUIDE 4 PEG M L |
| 00885556812846 | GLENOID DRL GUIDE 4 PEG XS S |
| 00885556812822 | GLENOID DRL GDE 10 DEG FW 4PEG M L LEFT |
| 00885556812815 | GLENOID DRL GDE 5 DEG FW 4PEG M L RGHT |
| 00885556812808 | GLENOID DRL GDE 5 DEG FW 4PEG M L LFT |
| 00885556812792 | GLENOID DRL GDE 10 DEG FW 4PEG XS S RGHT |
| 00885556812785 | GLENOID DRL GDE 10 DEG FW 4 PEG XS S LFT |
| 00885556812747 | GLENOID DRL GDE 5 DEG FW 4 PEG XS S RGHT |
| 00885556812730 | GLENOID DRL GDE 5 DEG FW 4 PEG XS S LEFT |
| 00885556812273 | CENTRAL SCREW DEPTH GUAGE |
| 00885556812266 | PERIPHERAL SCREW DEPTH GUAGE |
| 00885556812082 | CUT PROTECTOR SMALL |
| 00885556812020 | PERIPHERAL SCREW DRILL GUIDE |
| 00885556811917 | RESECTION GUIDE LARGE |
| 00885556811900 | RESECTION GUIDE MEDIUM |
| 00885556811894 | RESECTION GUIDE SMALL |
| 00885556810934 | 42MM REVERSE LINER PLS 6 LRG RETENTIVE |
| 00885556810927 | 42MM REVERSE LINER PLS 3 LRG RETENTIVE |
| 00885556810910 | 42MM REVERSE LINER PLS 0 LRG RETENTIVE |
| 00885556810903 | 38MM REVERSE LINER PLS 9 LRG RETENTIVE |
| 00885556810897 | 38MM REVERSE LINER PLS 6 LRG RETENTIVE |
| 00885556810880 | 38MM REVERSE LINER PLS 3 LRG RETENTIVE |
| 00885556810873 | 38MM REVERSE LINER PLS 0 LRG RETENTIVE |
| 00885556810866 | 34MM REVERSE LINER PLS 9 LRG RETENTIVE |
| 00885556810859 | 34MM REVERSE LINER PLS 6 LRG RETENTIVE |
| 00885556810842 | 34MM REVERSE LINER PLS 3 LRG RETENTIVE |
| 00885556810835 | 34MM REVERSE LINER PLS 0 LRG RETENTIVE |
| 00885556810828 | 42MM REVERSE LINER PLS 9 LRG |
| 00885556810811 | 42MM REVERSE LINER PLS 6 LRG |
| 00885556810804 | 42MM REVERSE LINER PLS 3 LRG |
| 00885556810798 | 42MM REVERSE LINER PLS 0 LRG |
| 00885556810781 | 38MM REVERSE LINER PLS 9 LRG |