DEXcam4™ Intra-oral camera sheaths PLU7611S

GUDID EKAV101149940

500 Count

DEXIS LLC

Cable/lead/sensor/probe cover, sterile

• Primary Device ID: EKAV101149940
• NIH Device Record Key: 48859a16-176b-455c-a0de-cd3d4f98675e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEXcam4™ Intra-oral camera sheaths
• Version Model Number: 1.011.4994
• Catalog Number: PLU7611S
• Company DUNS: 019717844
• Company Name: DEXIS LLC
• Device Count: 500
• 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: 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 10 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	0EKAV101149940 [Unit of Use]
HIBCC	EKAV101149940 [Primary]

FDA Product Code

• KQM: CAMERA, SURGICAL AND ACCESSORIES

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

On-Brand Devices [DEXcam4™ Intra-oral camera sheaths]

• EKAV101149940: 500 Count
• EKAV101149890: 100 Count