AccessGUDID - DEVICE: CrossRoads Tray System (00815432029051)

GUDID

Device Identifier (DI) Information

Brand Name: CrossRoads Tray System
Version or Model: MiniBunion Non-sterile Instrument Case
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 280020
Company Name: CROSSROADS EXTREMITY SYSTEMS

Primary DI Number: 00815432029051
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 058864308 *Terms of Use

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 Prevacuum Temperature 270 F (132 C) Exposure time 4 minutes Drying time 20 minutes The tray is 20.60 length x 9.80 width x 2.00 depth (inches).

Device Characteristics

What MRI safety information does the labeling contain?	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):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

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

FDA Product Code

[?]

Product Code	Product Code Name
KCT	Sterilization Wrap Containers, Trays, Cassettes & Other Accessories

FDA Premarket Submission

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: Yes

Sterilization Method [?]
Moist Heat or Steam Sterilization

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: aca8abc8-5ba7-46c4-af1a-ade743bc3274
Public Version Date: September 16, 2022
Public Version Number: 2
DI Record Publish Date: October 12, 2021