AccessGUDID - DEVICE: LEADER (00096295124033)

GUDID

Device Identifier (DI) Information

Brand Name: LEADER
Version or Model: 4902474
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 4902474
Company Name: Cardinal Health 110, Inc.

Primary DI Number: 00096295124033
Issuing Agency: GS1
Commercial Distribution End Date: August 30, 2021
Device Count: 10
Labeler D-U-N-S® Number*: 063997360 *Terms of Use

Device Description: Advanced Antibacterial Clear Waterproof Strong Strips; XL Adhesive Bandages; Triple Pad Technology; Helps Prevent Infection; 3x Absorbent Pad; Pain Free Film; Extra Large; 2 IN. x 4 IN.; Antibacterial Agent Benzalkonium Chloride 0.1%

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":	Yes
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?
47378	Skin-cover adhesive strip, antimicrobial	A small, narrow, flexible band (of fabric, plastic, paper, or other material) intended to cover a superficial wound, that is coated on one side with a pressure-sensitive adhesive and that has an absorbent pad prefilled (soaked) with an antiseptic to inhibit the growth of microorganisms. It may also be hypoallergenic and/or waterproof. Commonly referred to as a sticking plaster, it is intended for use in the home or a clinical setting. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KGX	Tape and bandage, adhesive

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 69ac7a80-692a-4faf-8503-518822fddeaf
Public Version Date: March 08, 2023
Public Version Number: 5
DI Record Publish Date: April 18, 2019