Primary Device ID | 00885556920985 |
NIH Device Record Key | 6b139fed-926a-48d5-a9a8-82ec677fb196 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Journey II |
Version Model Number | E0018278-2 |
Catalog Number | E0018278-2 |
Company DUNS | 045483575 |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00885556920985 [Primary] |
LXH | Orthopedic manual surgical instrument |
Steralize Prior To Use | true |
Device Is Sterile | false |
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
[00885556920985]
Moist Heat or Steam Sterilization
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2024-11-04 |
Device Publish Date | 2024-10-25 |
00885556741665 | TIBIAL BLOCK - RIGHT |
00885556741658 | TIBIAL BLOCK - LEFT |
00885556741375 | TIBIAL STEM STEP REAMER - 14MM |
00885556741368 | 2MM RECUT BLOCK |
00885556740453 | ANKLE CLAMP |
00885556740446 | MICRO ALIGNMENT GUIDE |
00885556740439 | MACRO ALIGNMENT GUIDE |
00885556739808 | 2MM TIBIAL BLOCK SHIM - RIGHT |
00885556739778 | 2MM TIBIAL BLOCK SHIM - LEFT |
00885556739679 | 2MM RECUT BLOCK |
00885556739372 | MEDIAL PLUS FIN PUNCH - SZ 7-8 R |
00885556739365 | MEDIAL PLUS FIN PUNCH - SZ 7-8 L |
00885556739358 | MEDIAL PLUS FIN PUNCH - SZ 5-6 R |
00885556739341 | MEDIAL PLUS FIN PUNCH - SZ 5-6 L |
00885556739334 | MEDIAL PLUS FIN PUNCH - SZ 3-4 R |
00885556739327 | MEDIAL PLUS FIN PUNCH - SZ 3-4 L |
00885556739310 | MEDIAL PLUS FIN PUNCH - SZ 1-2 R |
00885556739303 | MEDIAL PLUS FIN PUNCH - SZ 1-2 L |
00885556739273 | JII CR TRIAL INSERT SZ 1-2 9MM L |
00885556739150 | MODIFIED HOHMANN RETRACTOR |
00885556739143 | JII CR TRIAL INSERT SZ 7-8 12MM R |
00885556739136 | JII CR TRIAL INSERT SZ 7-8 11MM |
00885556739129 | JII CR TRIAL INSERT SZ 7-8 10MM R |
00885556739112 | JII CR TRIAL INSERT SZ 5-6 12MM R |
00885556739105 | JII CR TRIAL INSERT SZ 5-6 11MM R |
00885556739099 | JII CR TRIAL INSERT SZ 5-6 10MM R |
00885556739082 | JII CR TRIAL INSERT SZ 3-4 12MM R |
00885556739075 | JII CR TRIAL INSERT SZ 3-4 11MM R |
00885556739068 | JII CR TRIAL INSERT SZ 3-4 10MM R |
00885556739051 | JII CR TRIAL INSERT SZ 1-2 12MM R |
00885556739044 | JII CR TRIAL INSERT SZ 1-2 11MM R |
00885556739037 | JII CR TRIAL INSERT SZ 1-2 10MM R |
00885556739013 | JII CR TRIAL INSERT SZ 5-6 9MM R |
00885556738993 | JII CR TRIAL INSERT SZ 1-2 9MM R |
00885556738801 | INSERTION HANDLE |
00885556738795 | JII CR TRIAL INSERT SZ 7-8 12MM L |
00885556738788 | JII CR TRIAL INSERT SZ 7-8 11MM L |
00885556738771 | JII CR TRIAL INSERT SZ 7-8 10MM L |
00885556738764 | JII CR TRIAL INSERT SZ 5-6 12MM L |
00885556738757 | JII CR TRIAL INSERT SZ 5-6 11MM L |
00885556738740 | JII CR TRIAL INSERT SZ 5-6 10MM L |
00885556738733 | JII CR TRIAL INSERT SZ 3-4 12MM L |
00885556738726 | JII CR TRIAL INSERT SZ 3-4 11MM L |
00885556738719 | JII CR TRIAL INSERT SZ 3-4 10MM L |
00885556738702 | JII CR TRIAL INSERT SZ 1-2 12MM L |
00885556738696 | JII CR TRIAL INSERT SZ 1-2 11MM L |
00885556738689 | JII CR TRIAL INSERT SZ 1-2 10MM L |
00885556738672 | JII CR TRIAL INSERT SZ 7-8 9MM L |
00885556738665 | JII CR TRIAL INSERT SZ 5-6 9MM L |
00885556738658 | JII CR TRIAL INSERT SZ 3-4 9MM L |