AccessGUDID - DEVICE: Devon (10884527019007)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31159539
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31159539
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527019007
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 300
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Safety Tray with Adhesive Strip

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
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
MDM	INSTRUMENT, MANUAL, SURGICAL, GENERAL USE

FDA Premarket Submission

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

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

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

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Length: 9 Inch
Height: 1 Inch
Width: 3.75 Inch

Device Record Status

Public Device Record Key: 3777be4c-c8a6-4269-9ffc-495def4e6001
Public Version Date: September 12, 2024
Public Version Number: 8
DI Record Publish Date: June 23, 2018