DEVICE: ECOtip HVE Tips Sea Creatures (00723896010761)
Device Identifier (DI) Information
ECOtip HVE Tips Sea Creatures
10410014
In Commercial Distribution
71-08314
PRACTICON, INC.
10410014
In Commercial Distribution
71-08314
PRACTICON, INC.
Made from renewable, sustainable paper, ECOtip Earth-Friendly High Volume Evacuator Tips are the high-performance alternative to plastics. ECOtip is engineered and tested to provide outstanding stiffness, durability, and function. Food-grade coating eliminates moisture absorption and fraying during use. Tips fit standard HVE valves. Made under strict ISO standards from FDA-approved materials.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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37434 | Dental suction system cannula, single-use |
A semi-rigid or rigid hollow tubular component of a dental suction system designed to be inserted into the oral cavity for the aspiration and removal of blood, pus, saliva, debris, and water during a dental procedure. It is typically made of disposable plastic materials. This is a single-use device.
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FDA Product Code
[?]Product Code | Product Code Name |
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EHZ | Evacuator, Oral Cavity |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
1d2163df-c7e6-4d76-ad37-850338f2e537
August 20, 2018
1
July 19, 2018
August 20, 2018
1
July 19, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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00723896010778 | 10 | 00723896010761 | In Commercial Distribution | Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
00723896002926
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined