DEXIS Platinum™ intraoral sensor sheaths PLU975019

GUDID EKAV100826680

100 Count

DEXIS LLC

Instrument/equipment drape, single-use, non-sterile

• Primary Device ID: EKAV100826680
• NIH Device Record Key: 8da78605-215a-4688-802f-33ff92baae26
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXIS Platinum™ intraoral sensor sheaths
• Version Model Number: 1.008.2668
• Catalog Number: PLU975019
• Company DUNS: 019717844
• Company Name: DEXIS LLC
• Device Count: 100
• 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: +18888833947
• Email: support@dexis.com

Operating and Storage Conditions

• Handling Environment Temperature: Between 5 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	0EKAV100826680 [Unit of Use]
HIBCC	EKAV100826680 [Primary]

FDA Product Code

• MMP: Cover, barrier, protective

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-24

Devices Manufactured by DEXIS LLC

• EKAV100879340 - DEXIS 10 (DEXIS Imaging Suite): 2022-01-31
• EKAV101244750 - DEXIS™ Software: 2021-11-22 Software
• EKAV101289030 - DEXcam3™ intraoral cameras: 2021-11-22 Digital intraoral camera
• EKAV101289070 - DEXcam3™ intraoral cameras: 2021-11-22 Digital intraoral camera
• EKAV082250710 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor
• EKAV082250730 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor
• EKAV082250740 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor
• EKAV082251940 - DEXIS Platinum™ intraoral sensor: 2018-07-06 Digital intraoral sensor