AccessGUDID - DEVICE: Devon (10884527007493)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31140588
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 31140588
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527007493
Issuing Agency: GS1
Commercial Distribution End Date: July 01, 2023
Device Count: 3
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Magnetic Drape,Reusable

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):	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?
58976	Medical equipment/instrument drape, reusable	A noninvasive flexible polymer sheet/bag/sleeve designed to form a protective water-resistant enclosure around a piece of medical equipment/instrument (e.g., C-arm, surgical laser/camera/microscope, examination table/chair) and/or components (e.g., cables, tubes, headrest). It is intended as a hygienic barrier to protect the equipment/instrument from soiling and/or contamination when used inside, or within the vicinity, of a hygienic area. It is neither a dedicated handle cover, device cap nor an ultrasound transducer cover. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	TRAY, SURGICAL, INSTRUMENT

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: Keep dry;AVOID DIRECT SUNLIGHT

Clinically Relevant Size

[?]

Size Type Text
Width: 10 Inch
Length: 16 Inch

Device Record Status

Public Device Record Key: 6d4f8356-ca34-4b7b-a0b3-6bb020333d90
Public Version Date: September 11, 2024
Public Version Number: 7
DI Record Publish Date: June 23, 2018