CrossRoads Tray System - The CrossRoads Tray System is used in healthcare - CROSSROADS EXTREMITY SYSTEMS

Duns Number:058864308

Device Description: The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoa The CrossRoads Tray System is used in healthcare facilities to store and organize CrossRoads surgical instruments and components during cleaning/sterilization and during implant/prosthetic treatment. The CrossRoads Tray System are not intended on their own to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization pouch or sterilization wrap. Sterilization validations for the worst-case CrossRoads Tray System included surgical instruments such as drills, inserters, reamers, fixation pin, benders, and ratcheting handles. The CrossRoads Tray System is validated for a maximum load of 8.5 lbs (tray and instruments). Method Steam Sterilization (Moist Heat Sterilization) Cycle PrevacuumTemperature 270 F (132 C)Exposure time 4 minutesDrying time 20 minutesThe tray is 20.60 length x 9.80 width x 2.00 depth (inches).

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More Product Details

Catalog Number

280600

Brand Name

CrossRoads Tray System

Version/Model Number

CrossRoads Tray System

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"

-

For Single-Use

-

Prescription Use (Rx)

Yes

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

KCT

Product Code Name

Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

Device Record Status

Public Device Record Key

8f0d2d5a-a731-400c-b28a-929ac3a83b63

Public Version Date

September 16, 2022

Public Version Number

3

DI Record Publish Date

January 27, 2021

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"CROSSROADS EXTREMITY SYSTEMS" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 59
2 A medical device with a moderate to high risk that requires special controls. 713