AccessGUDID - DEVICE: Devon (10884527007585)

GUDID

Device Identifier (DI) Information

Brand Name: Devon
Version or Model: 31159455
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 31159455
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527007585
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: NS-3641 Rigid Light Handle

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?
44977	Medical equipment handle cover, single-use	A device designed specifically to cover the handle of a piece of medical equipment (e.g., operating light) to provide a physical sterile barrier between the handle and the hand of a healthcare professional, e.g., during a surgical procedure. It is typically a polymer device designed for attachment to a handle and may in addition provide grip for improved manipulation of the handle; it is not designed to cover other equipment components. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSY	Light, surgical, ceiling mounted

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
No Device Sizes

Device Record Status

Public Device Record Key: e4afabf7-6727-423f-9432-103ff63bb97f
Public Version Date: February 15, 2024
Public Version Number: 8
DI Record Publish Date: September 24, 2016