Cool Cassette 2 Size 10 Instrument Tray Clean Green - Building on the success of the original Cool - PRACTICON, INC.

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 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. Specify color.The Cool Cassette 2 Size 10 Instrument Tray with two built-in A-W syringe tip clips measures 8-3⁄8"L x 6-1⁄2"W x 1-3⁄8"H outside.

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More Product Details

Catalog Number

71-41911 GRE

Brand Name

Cool Cassette 2 Size 10 Instrument Tray Clean Green

Version/Model Number

7141911 GRE

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Device labeled as "Not made with natural rubber latex"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

OFX

Product Code Name

General Purpose Dental Tray

Device Record Status

Public Device Record Key

1d5e5c81-8613-4a74-a5be-e48d1ee57b66

Public Version Date

September 16, 2022

Public Version Number

6

DI Record Publish Date

July 20, 2018

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"PRACTICON, INC." Characteristics
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