EarClear Rx 90007

GUDID 00856331006224

EarClear Rx Disposable Tips- 3 pack

NUANCE MEDICAL, LLC

Slide-mounted-tissue dissection system excision tip IVD

• Primary Device ID: 00856331006224
• NIH Device Record Key: cd7313f0-717d-46a3-b092-015923b07a7f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: EarClear Rx
• Version Model Number: 90007
• Catalog Number: 90007
• Company DUNS: 078797666
• Company Name: NUANCE MEDICAL, LLC
• 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: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: +1(760)585-4849
• Email: george@cryodose.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00856331006224 [Primary]

FDA Product Code

• KCP: SYRINGE, ENT

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: 2018-11-26
• Device Publish Date: 2018-10-25

On-Brand Devices [EarClear Rx]

• 00856331006231: EarClear Rx Ear Wash Kit Rigid
• 00856331006224: EarClear Rx Disposable Tips- 3 pack
• 00856331006217: EarClear Rx Disposable Tips- 20 pack
• 00856331006200: EarClear Rx Ear Wash System Rigid
• 00856331006194: EarClear Rx Ear Wash Kit Flexible
• 00856331006187: EarClear Rx Ear Wash System Flexible
• 00856331006170: EarClear Rx Ear Wash Basin