Primary Device ID | 00885556841662 |
NIH Device Record Key | 0af514d7-8f16-41fb-a0e2-5dcb4e2b9850 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | XT Revision Ankle Replacement System |
Version Model Number | MJV101T |
Catalog Number | MJV101T |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885556841662 [Primary] |
HWT | TEMPLATE |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
[00885556841662]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2023-02-10 |
Device Publish Date | 2023-02-02 |
00885556842164 | TIBIAL ALIGNMENT GUIDE. NO BLOCK |
00885556842157 | 7 DEGREE BLOCK. TIBIAL ALIGNMENT |
00885556841761 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 3. THICK |
00885556841754 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 2. THICK |
00885556841747 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 1. THICK |
00885556841730 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 0. THICK |
00885556841723 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 3 |
00885556841716 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 2 |
00885556841709 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 1 |
00885556841693 | INTEGRA XT. TIBIAL TRIAL JIG. SIZE 0 |
00885556841686 | INTEGRA XT. TIBIAL TRIAL RASP. SIZE 3 |
00885556841679 | INTEGRA XT. TIBIAL TRIAL RASP SIZE 2 |
00885556841662 | INTEGRA XT. TIBIAL TRIAL RASP. SIZE 1 |
00885556841655 | INTEGRA XT. TIBIAL TRIAL RASP. SIZE 0 |
00885556841648 | INTEGRA XT. SLOPED TALAR CUTTING GUIDE |
00885556841624 | INTEGRA XT. DRILL 4.5 MM |
00885556841600 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 3. LEFT |
00885556841594 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 2. LEFT |
00885556841587 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 1. LEFT |
00885556841570 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 0. LEFT |
00885556841563 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 3. RIGHT |
00885556841556 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 2. RIGHT |
00885556841549 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 1. RIGHT |
00885556841532 | INTEGRA XT. SLOPED TALAR TRIAL. SIZE 0. RIGHT |
00885556841518 | INTEGRA XT. IN SITU POLY INSERTER |
00885556841501 | INTEGRA XT. DRILL. TAPERED |
00885556841495 | INTEGRA XT. PUNCHING TIP |
00885556841471 | INTEGRA XT. TIBIAL HOLDER |
00885556841464 | INTEGRA XT. JOINT DISTRACTOR. LEFT |
00885556841457 | INTEGRA XT. JOINT DISTRACTOR. RIGHT |
00885556841440 | INTEGRA XT. TIBIAL OSTEOTOME |
00885556842171 | INTEGRA XT. ATTACHMENT SCREW |
00885556842140 | INTEGRA XT. TRIAL INSERT. SIZE 00. LEFT. TH21 |
00885556842133 | INTEGRA XT. TRIAL INSERT. SIZE 00. LEFT. TH19 |
00885556842126 | INTEGRA XT. TRIAL INSERT. SIZE 00. RIGHT. TH21 |
00885556842119 | INTEGRA XT. TRIAL INSERT. SIZE 00. RIGHT. TH19 |
00885556842102 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH21 |
00885556842096 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH19 |
00885556842089 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH17 |
00885556842072 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH15 |
00885556842065 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH13 |
00885556842058 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH11 |
00885556842041 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH10 |
00885556842034 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH9 |
00885556842027 | INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH8 |
00885556842010 | INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH21 |
00885556842003 | INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH19 |
00885556841990 | INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH17 |
00885556841983 | INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH15 |
00885556841976 | INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH13 |