DuraLock® PLUS

GUDID 00190730088901

DuraLock® PLUS IMPRESSION TRAYS LARGE LOWER-YELLOW 50PK

ORTHO TECHNOLOGY, INC.

Dental impression tray, single-use

• Primary Device ID: 00190730088901
• NIH Device Record Key: 4dc1e483-85ef-471c-a28f-c3313ae3e3a1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DuraLock® PLUS
• Version Model Number: 501-005L
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	00190730088901 [Primary]

FDA Product Code

• EHY: TRAY, IMPRESSION, PREFORMED

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-24
• Device Publish Date: 2021-09-16

On-Brand Devices [DuraLock® PLUS]

• 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