DEVICE: Cool Cassette 10 Instrument Container Green (00723896001288)

Device Identifier (DI) Information

Cool Cassette 10 Instrument Container Green
7039771 GRE
In Commercial Distribution
70-39771 GRE
PRACTICON, INC.
00723896001288
GS1

1
119193803 *Terms of Use
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 5 Instrument Container includes one A-W syringe tip clip. Measures 8"L x 3-5⁄8"W x 1-3⁄8"H outside. Specify color.
CLOSE

Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
No
No
No

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?
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.
Active false
CLOSE

FDA Product Code

[?]
Product Code Product Code Name
OFX General Purpose Dental Tray
CLOSE

FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization

No
Yes
Sterilization Method [?]
Moist Heat or Steam Sterilization
CLOSE

Storage and Handling

[?]
Storage and Handling
No storage/handling found
CLOSE

Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
CLOSE

Device Record Status

fc7968c9-b844-4ca2-a28a-7179122fc218
September 16, 2022
6
July 20, 2018
CLOSE

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
CLOSE

Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
CLOSE

Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
CLOSE

Production Identifier(s) in UDI

[?]
No
No
No
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
CLOSE