| Primary Device ID | 00885556861530 |
| NIH Device Record Key | 849f6400-fcf8-443f-96f8-ac1007b3ac88 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Titan Modular Shoulder System |
| Version Model Number | PEG-0922-074-02 |
| Catalog Number | PEG092207402 |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556861530 [Primary] |
| LXH | Orthopedic manual surgical instrument |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
[00885556861530]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-06-26 |
| Device Publish Date | 2023-06-16 |
| 00885556860779 | TSS TRIAL INSERTER/EXTRACTOR. 2.5 |
| 00885556862964 | GLENOID PEGGED TRIAL LARGEL |
| 00885556862957 | GLENOID KEELED TRIAL LARGE |
| 00885556862940 | GLENOID PEGGED TRIAL MEDIUM |
| 00885556862933 | GLENOID KEELED TRIAL MEDIUM |
| 00885556862926 | GLENOID PEGGED TRIAL SMALL |
| 00885556862919 | GLENOID KEELED TRIAL SMALL |
| 00885556862902 | GLENOID PEGGED TRIAL EXTRA SMALL |
| 00885556862896 | GLENOID KEELED TRIAL EXTRA SMALL |
| 00885556862827 | DEFINITIVE STEM PRIMARY BODY TRIAL 14STD |
| 00885556862810 | DEFINITIVE STEM PRIMARY BODY TRIAL 14SML |
| 00885556862803 | DEFINITIVE STEM PRIMARY BODY TRIAL 14LRG |
| 00885556862797 | DEFINITIVE STEM PRIMARY BODY TRIAL 12STD |
| 00885556862780 | DEFINITIVE STEM PRIMARY BODY TRIAL 10STD |
| 00885556862773 | DEFINITIVE STEM PRIMARY BODY TRIAL 10SML |
| 00885556862766 | DEFINITIVE STEM PRIMARY BODY TRIAL 10LRG |
| 00885556862759 | DEFINITIVE STEM PRIMARY BODY TRIAL 08STD |
| 00885556862742 | BODY TRIAL 14 STANDARD |
| 00885556862735 | BODY TRIAL 14 SMALL |
| 00885556862728 | BODY TRIAL 14 LARGE |
| 00885556862711 | BODY TRIAL 12 STANDARD |
| 00885556862704 | BODY TRIAL 10 STANDARD |
| 00885556862698 | BODY TRIAL 10 SMALL |
| 00885556862681 | BODY TRIAL 10 LARGE |
| 00885556862674 | BODY TRIAL 8 STANDARD |
| 00885556862407 | HEAD CUTTING TEMPLATE. RIGHT |
| 00885556862391 | HEAD CUTTING TEMPLATE. LEFT |
| 00885556861554 | FIXATION PIN |
| 00885556861530 | ANTI-ROTATION PEG |
| 00885556860809 | TSS HEAD IMPACTOR |
| 00885556860618 | HUMERAL DEPTH STOP |
| 00885556860601 | MINI GLENOID HOLDER |
| 00885556860595 | GLENOID HOLDER |
| 00885556860526 | ANTI-ROTATION PEG HOLDER |
| 00885556860519 | STEM TRIAL HANDLE |
| 00885556860243 | SLOTTED MALLET |
| 00885556860151 | TSS GLENOID SOLID PEG DRILL |
| 00885556859995 | TSS MODIFIED RETRACTOR BASE |
| 00885556859254 | TAPER ADAPTER |
| 00885556859247 | STARTER AWL 6MM |
| 00885556859209 | TRIAL ADAPTOR TSS |
| 00885556837818 | CEMENTED LONG STEM TRIAL SZ. 12X165 |
| 00885556837801 | CEMENTED LONG STEM TRIAL SZ. 12X125 |
| 00885556837795 | CEMENTED LONG STEM TRIAL SZ. 10X165 |
| 00885556837788 | CEMENTED LONG STEM TRIAL SZ. 10X125 |
| 00885556837771 | CEMENTED LONG STEM TRIAL SZ. 08X165 |
| 00885556837764 | CEMENTED LONG STEM TRIAL SZ. 08X125 |
| 00885556837702 | CEMENTED LONG STEM. 12MMX165MM |
| 00885556837696 | CEMENTED LONG STEM. 12MMX125MM |
| 00885556837689 | CEMENTED LONG STEM. 10MMX165MM |