TC-100 XT001040-1
GUDID 00885556653807
4.5MM PROXIMAL TIBIA LOCKING PLATE 4H
Smith & Nephew, Inc.
Orthopaedic fixation plate, non-bioabsorbable, non-sterile| Primary Device ID | 00885556653807 |
| NIH Device Record Key | afee9f64-aa05-4bd1-a416-a1b9e4a031dd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TC-100 |
| Version Model Number | XT001040-1 |
| Catalog Number | XT001040-1 |
| 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556653807 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K993106
FDA Product Code
| HRS | Plate, fixation, bone |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
[00885556653807]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-06-30 |
On-Brand Devices [TC-100]
| 00885556728826 | SS 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H |
| 00885556728734 | CANNULATED DEPTH GAUGE |
| 00885556728727 | CANNULATED DEPTH GAUGE |
| 00885556725351 | MULTI PIN GUIDE |
| 00885556725276 | CANNULATED DEPTH GAUGE |
| 00885556725122 | CANNULATED BLADE PLATE DRIVER |
| 00885556722756 | UNIVERSAL SLAP HAMMER W/CHISEL EXTRACTOR |
| 00885556718537 | K-WIRE DEPTH GAUGE |
| 00885556718520 | WIRE W/LOOP END |
| 00885556718513 | COMPRESSION DEVICE NUT |
| 00885556718506 | KING TONG TENSION NUT |
| 00885556717301 | 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H |
| 00885556706329 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 7 |
| 00885556704776 | SS 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H |
| 00885556698341 | SS 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H |
| 00885556696644 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6 |
| 00885556696637 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5 |
| 00885556686959 | SCREW MEASURING GAUGE FOR 358MM GUIDE WIRES |
| 00885556674598 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6 |
| 00885556674581 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5 |
| 00885556674116 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5 |
| 00885556672402 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 7 |
| 00885556672396 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6 |
| 00885556672389 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 6 |
| 00885556672372 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 4H 5 |
| 00885556668290 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE 6H 4 |
| 00885556654774 | DIRECT MEASURING GAUGE 358MM GUIDE PIN |
| 00885556654439 | 4.5MM 130 DEG ADOLESCENT CANNULATED LOCKING BLADE PLATE, 4H |
| 00885556654224 | MODIFIED DIRECT MEASURING GAUGE FOR 3.2MM X 230MM GUIDE PINS |
| 00885556653807 | 4.5MM PROXIMAL TIBIA LOCKING PLATE 4H |
| 00885556647035 | 130 DEG ADOLESCENT CANNULATED 3.5MM LOCKING BLADE PLATE 4H 7 |
| 00885556646779 | K-WIRE DEPTH GAUGE |
| 00885556590737 | SS Calcaneal Plate 3H LT |
| 00885556590720 | SS Calcaneal Plate 3H RT |
| 00885556590645 | SS Calcaneal Plate 4H RT |
| 00885556590577 | SS Calcaneal Plate 4H LT |
| 00885556590560 | SS Pubic Symphysis Locking Plate |
| 00885556263242 | SLOTTED MALLET |
| 00885556226858 | INFANT/CHILD BLADE PLATE DRIVER |
| 00885556224267 | 1.5 X 7 CORT SCR HEX HD STERILE |
| 00885556224250 | 1.5 X 8 CORT SCR HEX HD STERILE |
| 00885556224243 | 1.5 X 9 CORT SCR HEX HD STERILE |
| 00885556224236 | 1.5 X 10 CORT SCR HEX HD STERILE |
| 00885556224229 | 1.5 X 11 CORT SCR HEX HD STERILE |
| 00885556224212 | 1.5 X 12 CORT SCR HEX HD STERILE |
| 00885556224205 | 1.5 X 14 CORT SCR HEX HD STERILE |
| 00885556224199 | 1.5 X 16 CORT SCR HEX HD STERILE |
| 00885556224182 | 2.0 X 10ORT SCR HEX HD STERILE |
| 00885556224175 | 2.0 X 12 CORT SCR HEX HD STERILE |
| 00885556224168 | 2.0 X 14 CORT HEX HD STERILE |
Trademark Results [TC-100]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TC-100 76381503 2734136 Live/Registered |
Smith & Nephew, Inc. 2002-03-12 |
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