PROMOS 75006625
GUDID 07611996083583
PROMOS TRIAL BODY 35MM
Smith & Nephew, Inc.
Humeral body prosthesis trial| Primary Device ID | 07611996083583 |
| NIH Device Record Key | 9d269024-0985-44d5-b411-2b97220cb74d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PROMOS |
| Version Model Number | 75006625 |
| Catalog Number | 75006625 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| 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 | 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 |
Customer Support Contacts
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07611996083583 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K121714
FDA Product Code
| HSD | PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
[07611996083583]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2015-11-25 |
On-Brand Devices [PROMOS]
| 00885556654897 | PROMOS REVERSE BODY DIAMETER 36/21MM |
| 00885556654880 | PROMOS REVERSE BODY DIAMETER 36/18MM |
| 07612883015922 | VKS/PROMOS RESECTION STYLUS |
| 07611996127225 | SLEEVE/HEAD IMPACTOR |
| 07611996127218 | HOLDING FORK |
| 07611996127201 | SLEEVE ALIGNMENT GUIDE |
| 07611996127195 | PRIMARY ALIGNMENT GUIDE |
| 07611996120554 | PLUS PROMOS INCLINATION SET 26MM |
| 07611996120547 | PLUS PROMOS INCLINATION SET 24MM |
| 07611996120530 | PLUS PROMOS INCLINATION SET 22MM |
| 07611996120523 | PLUS PROMOS INCLINATION SET 20MM |
| 07611996117738 | PROMOS REVERSE GLENOID DRILL DIA4 |
| 07611996115543 | PROMOS INSERTER 5 |
| 07611996115529 | PROMOS RASP STEM 5 |
| 07611996115390 | PROMOS TRIAL HUMERAL STEM 5 |
| 07611996114539 | PROMOS SCREW REMOVER OLD STANDARD BODY SW3.5 |
| 07611996114522 | PROMOS SCREW REMOVER T25 |
| 07611996112641 | PROMOS REV SCREW LOOSENING ADAP GLENO |
| 07611996112139 | PROMOS RELEASE CLAMP |
| 07611996112122 | PROMOS RELEASE ADAPTER GLENOSPHERE |
| 07611996111262 | PROMOS REVERSE CUTTING ADAPTER RIGHT |
| 07611996111255 | PROMOS REVERSE CUTTING ADAPTER LEFT |
| 07611996111248 | PROMOS REV TRIAL FIXATION SCREW INSERTER |
| 07611996111231 | PROMOS REVERSE ORIENTATION DEVICE DIA42 |
| 07611996111224 | PROMOS REVERSE ORIENTATION DEVICE DIA36 |
| 07611996111217 | PROMOS REVERSE REAMER GUIDE FIXAT.DEVICE |
| 07611996111200 | PROMOS REV TRIAL GLENOSPHERE CENTRIC DIA42 |
| 07611996111194 | PROMOS REV TRIAL GLENOSPHERE CENTRIC DIA36 |
| 07611996111156 | PROMOS REVERSE ORIENTATION PIN |
| 07611996111149 | PROMOS REVERSE CUTTING DEVICE |
| 07611996111132 | PROMOS REV GLENOSPHERE PERIPHERAL REAMER |
| 07611996111125 | PROMOS REV TRIAL GLENOSPHERE ECCENTR. DIA42 |
| 07611996111118 | PROMOS REV TRIAL GLENOSPHERE ECCENTR. DIA36 |
| 07611996111101 | PROMOS REVERSE GLENOSPHERE DRILL GUIDE |
| 07611996111095 | PROMOS REVERSE ADAPT.GLENOSPHERE ECCENTR |
| 07611996111088 | PROMOS REVERSE ADAPT.GLENOSPHERE CENTRIC |
| 07611996111071 | PROMOS REVERSE FIXATION SCREW INSERTER |
| 07611996111064 | PROMOS REVERSE INSERTER |
| 07611996109597 | PROMOS DRILL SLEEVE 4 |
| 07611996109573 | PROMOS DRIVE SHAFT |
| 07611996109566 | PROMOS GUIDE WIRE DIA3 |
| 07611996092196 | PROMOS CASE 6 PROXIMAL STANDARD |
| 07611996092189 | PROMOS CASE 5 PROXIMAL STANDARD |
| 07611996092172 | PROMOS CASE 4 STEM STANDARD/REVERSE |
| 07611996092165 | PROMOS CASE 3 STEM STANDARD/REVERSE |
| 07611996092141 | PROMOS CASE 7 EXTRACTOR STANDARD/REVERSE |
| 07611996092134 | PROMOS TRAY 5+6 PROXIMAL STANDARD |
| 07611996092127 | PROMOS CASE 5+6 PROXIMAL STANDARD |
| 07611996092110 | PROMOS TRAY 3+4 STEM STANDARD/REVERSE |
| 07611996092097 | PROMOS CASE 2 GLENOID STANDARD |
Trademark Results [PROMOS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 PROMOS 85758698 4515577 Live/Registered |
ACUCAREIRA QUATA S/A 2012-10-19 |
 PROMOS 78078502 2536873 Dead/Cancelled |
Promo International, Inc. 2001-08-09 |
 PROMOS 78076698 2558981 Dead/Cancelled |
Promo International, Inc. 2001-07-31 |
 PROMOS 76316310 2863198 Live/Registered |
SMITH & NEPHEW ORTHOPAEDICS AG 2001-09-24 |
 PROMOS 75892125 2687774 Dead/Cancelled |
Promo International, Inc. 2000-01-07 |
 PROMOS 75764471 2851089 Dead/Cancelled |
AccessVia, Inc. 1999-07-30 |
 PROMOS 75401288 2247409 Dead/Cancelled |
Promo International, Inc. 1997-12-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.