Duns Number:119193803
Device Description: Building on the success of the original Cool Cassette, the world’s first flexible silicone Building on the success of the original Cool Cassette, the world’s first flexible silicone instrument trays, 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. Specify color.The Cool Cassette 2 14 Instrument Tray with two built-in A-W syringe tip clips measures 8-3⁄8"L x 8-3⁄8"W x 1-3⁄8"H outside.
Catalog Number
71-41913 PUR
Brand Name
Cool Cassette 2 Size 14 Instrument Tray Pure Purple
Version/Model Number
7141913 PUR
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
OFX
Product Code Name
General Purpose Dental Tray
Public Device Record Key
d6cf5069-9be0-40aa-9518-60b790905ddb
Public Version Date
September 16, 2022
Public Version Number
6
DI Record Publish Date
July 20, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
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Package Discontinue Date
-
Package Status
-
Package Type
-
Device Class | Device Class Description | No of Devices |
---|---|---|
1 | A medical device with low to moderate risk that requires general controls | 93 |
2 | A medical device with a moderate to high risk that requires special controls. | 2 |