Ex-Fix E0016048-2
GUDID 00885556721315
PARTIALLY THREADED ROD 250MM
Smith & Nephew, Inc.
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 00885556721315 |
| NIH Device Record Key | 2d954978-1121-4ea7-8e5e-328992785fc9 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ex-Fix |
| Version Model Number | E0016048-2 |
| Catalog Number | E0016048-2 |
| 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 | true |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556721315 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K994143
FDA Product Code
| JDW | PIN, FIXATION, THREADED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
[00885556721315]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-07-16 |
| Device Publish Date | 2018-06-15 |
On-Brand Devices [Ex-Fix]
| 00885556740538 | PARTIALLY THREADED ROD 400MM |
| 00885556740521 | PARTIALLY THREADED ROD 330MM |
| 00885556740507 | PARTIALLY THREADED ROD 300MM |
| 00885556732199 | ROD PUSHER |
| 00885556730256 | PARTIALLY THREADED ROD 400MM |
| 00885556722565 | MODIFIED DOUBLE PIN DRILL SLEEVE |
| 00885556721339 | PARTIALLY THREADED ROD 330MM |
| 00885556721322 | PARTIALLY THREADED ROD 300MM |
| 00885556721315 | PARTIALLY THREADED ROD 250MM |
| 00885556721308 | PARTIALLY THREADED ROD 220MM |
| 00885556720950 | ARM WITH FEMALE DOVE TAIL |
| 00885556720943 | VICE WITH MALE DOVE TAIL |
| 00885556719961 | SPIKED ELEVATOR - ANGLED |
| 00885556719954 | SPIKED ELEVATOR - STRAIGHT |
| 00885556719565 | MODIFIED TISSUE PROTECTOR HANDLE |
| 00885556719343 | ANTITORQUE WIRE TENSIONER |
| 00885556718193 | MODIFIED TISSUE PROTECTOR HANDLE |
| 00885556710197 | Swivel 10mm Socket 1/4 Drive |
| 00885556702017 | THINNED 10MM WRENCH |
| 00885556692509 | TSF 300MM 1/3 RING |
| 00885556692493 | TSF 275MM 1/3 RING |
| 00885556692486 | TSF 255MM 1/3 RING |
| 00885556692479 | TSF 230MM 1/3 RING |
| 00885556692431 | 3.2MM X 450MM DRILL TIP GUIDE PIN |
| 00885556687932 | 10MM SOCKET |
| 00885556687925 | T HANDLED TORQUE WRENCH |
| 00885556684054 | K-WIRE DEPTH GAUGE |
| 00885556684047 | WIRE W/ LOOP END |
| 00885556684030 | COMPRESSION DEVICE NUT |
| 00885556684023 | KING TONG TENSION NUT |
| 00885556669402 | T HANDLED TORQUE WRENCH |
| 00885556667958 | SWIVEL 10MM SOCKET WRENCH |
| 00885556663585 | 3.2X450MM DRILL TIP GUIDE PIN |
| 00885556657096 | Dual ball spike pelvic forceps |
| 00885556657089 | Ball spike/paddle pelvic forceps |
| 00885556754887 | SPIKED ELEVATOR - STRAIGHT |
| 00885556778180 | SWIVEL 10MM SOCKET |
| 00885556759264 | SWIVEL 10MM SOCKET 1/4 DRIVE |
| 00885556759257 | 10MM SOCKET |
| 00885556759240 | T HANDLED TORQUE WRENCH |
| 00885556810576 | TSF 205MM 1/3 RING |
| 00885556810569 | TSF 180MM 1/3 RING |
| 00885556810552 | TSF 155MM 1/3 RING |
| 00885556810545 | TSF 130MM 1/3 RING |
| 00885556810538 | TSF 105MM 1/3 RING |
| 00885556868799 | SWIVEL 10MM SOCKET WRENCH |
| 00885556868782 | 10MM SOCKET |
| 00885556868775 | T HANDLED TORQUE WRENCH |
| 00885556885215 | SHORTENED 205 2/3 RING |
| 00885556885192 | SHORTENED 155 2/3 RING |
Trademark Results [Ex-Fix]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EX-FIX 77123293 not registered Dead/Abandoned |
Vilex, Inc. 2007-03-06 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.