FDA.report

CrossRoads Modular Tray System

Primary DI
00810112598179
Brand
CrossRoads Modular Tray System
Company
CROSSROADS EXTREMITY SYSTEMS
Model
OUTER LID CROSSROADS TRAY - NEW
Catalog number
2806OLPKG
Device description
OUTER LID CROSSROADS TRAY - NEW
Published
2024-08-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KCTSterilization Wrap Containers, Trays, Cassettes & Other Accessories

Product Code Classifications

CodeDeviceSpecialtyClass
KCTSterilization Wrap Containers, Trays, Cassettes & Other AccessoriesGeneral Hospital2

Premarket Submissions

SubmissionSupplement
K241050000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K241050000CrossRoads Modular Tray SystemCrossroads Extremity Systems2024-07-16KCT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810112598179PrimaryGS10

GMDN Terms

TermDefinition
Instrument tray, reusableA 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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
058864308
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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