DEVICE: Cool Cassette 2 Size 5 Instrument Tray Cool Coral (00723896008850)
Device Identifier (DI) Information
Cool Cassette 2 Size 5 Instrument Tray Cool Coral
7141910 COR
In Commercial Distribution
71-41910 COR
PRACTICON, INC.
7141910 COR
In Commercial Distribution
71-41910 COR
PRACTICON, INC.
Building on the success of the original Cool Cassette, the world’s first flexible silicone instrument containers, our Cool Cassette 2 Instrument Trays offer all the benefits of the original, with several design improvements to make your instrument-handling procedures easier and safer than ever!Like the original, Cool Cassette 2 is:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges to tear gloves or injure hands.Quieter—No metal to create noise, dull instruments, or scratch mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely.More compact—Lids nest underneath, reducing space needed.Longer lasting—No hinges, locks, or moving parts to break.More colorful—Color-coded for operatory or instrument setups.Lighter—10% lighter weight than equivalent steel cassettes.Lower cost—About 40% less than equivalent steel cassettes.Based on feedback from users, the redesigned Cool Cassette 2 goes even further with the following improvements:Larger vent holes—For increased water and steam penetration.Wraparound perforations—For full drainage at any angle.Built-in lock buttons—Eliminate the need for safety bands.Longer—By 1/4" to accommodate ultrasonic scaler inserts.NEW size—In addition to the original three sizes, the new 10XL includes a 5-5⁄8" by 2-1⁄2"compartment for handpieces, syringes, or other items.NEW color—In addition to the original three colors, Cool Coral expands your color-coding options.Interior instrument saddles can be cut with scissors to accommodate large-handled instruments, if desired. All containers hold instruments up to 7-1⁄8" long. Available in 5, 10, 10XL, and 14 instrument sizes. Fully sterilizable to 375°F.
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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12143 | Instrument tray, reusable |
A container intended to provide a suitable platform for placing/containing many medical/surgical/dental instruments and related items for use during a clinical procedure; it might, in addition, be used during, but not dedicated to, reprocessing/sterilization procedures. It is a receptacle in one of a variety of designs, typically with moulded positions for placing the instruments; it might include a lid and/or removable identification tags. This is a reusable device.
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FDA Product Code
[?]Product Code | Product Code Name |
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OFX | General Purpose Dental Tray |
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
740a6496-e66d-4c5b-b9fa-632ed50af398
September 16, 2022
6
July 20, 2018
September 16, 2022
6
July 20, 2018
Alternative and Additional Identifiers Additional Identifiers
Package DI
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Secondary DI
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Unit of Use DI
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Unit of Use DI Number:
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CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined