FDA.reportPublic FDA data

CrossRoads Tray System

Primary DI
00815432028924
Brand
CrossRoads Tray System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
CrossRoads Tray System
Catalog number
280600
Device description
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).
Published
2021-01-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815432028924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815432028924008154320289248154320289240815432028924

GMDN Terms#

Term, Definition table
TermDefinition
Instrument tray, reusableA container intended to provide a suitable platform for placing/containing many medical/surgical 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 may be in the form of a shallow vessel with a raised rim, a deeper cassette-like device, or a flat or angled surface; it might include a lid. It may be designed to fit into other devices such as supply trolleys, storage systems and sterilizers, or designed to attach to a surgical/treatment table where it may be placed over the patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
058864308
Device count
1
Lot or batch
true
Serial number
true
Sterilization required before use
true

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