AccessGUDID - DEVICE: Uni-Patch (10884521168374)

GUDID

Device Identifier (DI) Information

Brand Name: Uni-Patch
Version or Model: EP85159
Commercial Distribution Status: In Commercial Distribution
Catalog Number: EP85159
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521168374
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 4
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: S Series Stimulating Electrodes,2804, Silver Carbon, Aloe Vera Gel

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):	Yes
Over the Counter (OTC):	No
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?
35695	Gastro-oesophageal antireflux prosthesis	An implantable device introduced into the gastro-oesophageal sphincter to reduce a sliding hiatal hernia, preventing the reflux of gastric contents into the oesophagus. It typically consists of a toroidal, C-shaped elastomer ring filled with a silicone gel that includes a polyester tie to secure the ring around the gastro-oesophageal junction; it is intended for surgical implantation under the diaphragm to hold the lower oesophagus in place as an alternative to traditional surgical fixation of the stomach (i.e., gastropexy) or fundoplication. This GMDN code may reflect old technology.	Active	true

FDA Product Code

[?]

Product Code	Product Code Name
DRX	Electrode, electrocardiograph

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
Outer Diameter: 2.75 Inch

Device Record Status

Public Device Record Key: 826d4105-d984-4f00-ab9d-730383b6700c
Public Version Date: September 04, 2023
Public Version Number: 6
DI Record Publish Date: September 24, 2016