Primary Device ID | 00190730088840 |
NIH Device Record Key | 8519f40e-c5e9-4908-b5e9-e2130657b770 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | DuraLock® PLUS |
Version Model Number | 501-002L |
Company DUNS | 781772017 |
Company Name | ORTHO TECHNOLOGY, INC. |
Device Count | 1 |
DM Exempt | true |
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 | true |
Lot Batch | true |
Serial Number | false |
Manufacturing Date | true |
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 |
Device Issuing Agency | Device ID |
---|---|
GS1 | 00190730088840 [Primary] |
EHY | TRAY, IMPRESSION, PREFORMED |
Steralize Prior To Use | false |
Device Is Sterile | false |
Public Version Status | New |
Device Record Status | Published |
Public Version Number | 1 |
Public Version Date | 2021-09-24 |
Device Publish Date | 2021-09-16 |
00190730088925 | DuraLock® PLUS IMPRESSION TRAYS EXTRA LARGE LOWER-PURPLE 50PK |
00190730088918 | DuraLock® PLUS IMPRESSION TRAYS EXTRA LARGE UPPER-PURPLE 50PK |
00190730088901 | DuraLock® PLUS IMPRESSION TRAYS LARGE LOWER-YELLOW 50PK |
00190730088895 | DuraLock® PLUS IMPRESSION TRAYS LARGE UPPER-YELLOW 50PK |
00190730088888 | DuraLock® PLUS IMPRESSION TRAYS MEDIUM LOWER-GREEN 50PK |
00190730088871 | DuraLock® PLUS IMPRESSION TRAYS MEDIUM UPPER-GREEN 50PK |
00190730088864 | DuraLock® PLUS IMPRESSION TRAYS SMALL LOWER-BLUE 50PK |
00190730088857 | DuraLock® PLUS IMPRESSION TRAYS SMALL UPPER-BLUE 50PK |
00190730088840 | DuraLock® PLUS IMPRESSION TRAYS EXTRA SMALL LOWER-ORANGE 50PK |
00190730088833 | DuraLock® PLUS IMPRESSION TRAYS EXTRA SMALL UPPER-ORANGE 50PK |
00190730088826 | DuraLock® PLUS IMPRESSION TRAYS PEDO SMALL LOWER-RED 50PK |
00190730088819 | DuraLock® PLUS IMPRESSION TRAYS PEDO SMALL UPPER-RED 50PK |
00190730088802 | DuraLock® PLUS IMPRESSION TRAYS INTRODUCTORY KIT 60 trays, 5 trays of each size |