AccessGUDID - DEVICE: Devon (20884527018809)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31140380
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 31140380
Company Name: Cardinal Health, Inc.

Primary DI Number: 20884527018809
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Hands-free Transfer Tray,Instrument Holder, 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?
46219	Medical device adhesive	A substance primarily intended to promote the bonding of two surfaces in the manufacture of medical devices (e.g., active implantable devices). After application, this device cannot be reused.	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: Yes
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: c314117c-0c98-4dc6-9a84-157b211b8fa1
Public Version Date: December 31, 2024
Public Version Number: 5
DI Record Publish Date: June 23, 2018