Duns Number:119193803
Device Description: As the world's first flexible silicone instrument containers, Cool Cassettes will save you As the world's first flexible silicone instrument containers, Cool Cassettes will save your hands from heat and sharp edges, save workspace, save instruments from scratches—and save you money!Smooth, soft-touch Cool Cassettes are superior to metal cassettes in many ways:Cooler—Solid silicone construction dissipates heat faster than steel for faster removal from the autoclave.Safer—No sharp edges that can tear gloves and pouches or injure hands.Quieter—No metal surfaces to create noise or scratch instruments and mirrors.Easier to open—Snap on lids "peel off" easily yet hold securely. Two safety bands included add extra security when storing the containers on their sides.More compact—Lids stack underneath to reduce tray workspace requirements.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.Due to their solid silicone construction, 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. Fully sterilizable to 375°F.The Cool Cassette 14 Instrument Container includes two A-W syringe tip clips. Measures 8"L x 8-1⁄8"W x 1-3⁄8"H outside.
Catalog Number
70-39772 PUR
Brand Name
Cool Cassette 14 Instrument Container Purple
Version/Model Number
7039772 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
49c7303c-f700-477e-91d0-a1fd744eadcc
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 |