AccessGUDID - DEVICE: Wings (10884527001811)

GUDID

Device Identifier (DI) Information

Brand Name: Wings
Version or Model: 6597B20
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 6597B20
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527001811
Issuing Agency: GS1
Commercial Distribution End Date: October 09, 2023
Device Count: 80
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: Contoured Insert Pad,Heavy

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?
35817	Incontinence pants liner	A disposable pad composed of absorbent materials that is worn inside incontinence pants to catch and retain urine from an incontinent person. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EYQ	GARMENT, PROTECTIVE, FOR INCONTINENCE

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: This side up;

Clinically Relevant Size

[?]

Size Type Text
Length: 26 Inch
Width: 14 Inch

Device Record Status

Public Device Record Key: a69ac253-611e-4f14-90f7-bd03e6386ff4
Public Version Date: October 09, 2023
Public Version Number: 4
DI Record Publish Date: June 27, 2018