AccessGUDID - DEVICE: LEADER (00096295111712)

GUDID

Device Identifier (DI) Information

Brand Name: LEADER
Version or Model: 3463122
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 3463122
Company Name: Cardinal Health 110, Inc.

Primary DI Number: 00096295111712
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 063997360 *Terms of Use

Device Description: Non-Stick Pads For Covering Wounds; Triple Layer Protection Won't Stick to Wounds; Latex Free; All One Size 3 IN. x 4 IN.

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?
48131	Non-woven gauze pad	A non-medicated device in the form of a patch or swab (also referred to as a sponge) made from non-woven material (e.g., rayon/polyester) and primarily designed to absorb fluids for medical purposes. It is typically used to cover/clean wounds or abrasions and absorb their exudates, absorb body-surface exudates, or to apply topical medications; it is intended to produce less lint and be less adherent than basic woven gauze pads; it does not include petrolatum; in some cases, the device’s packaging may be used as a disposable tray. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAC	Dressing, wound, hydrophilic

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: 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: 97ae3b08-5e6f-4a16-8cb8-192816402bb2
Public Version Date: November 07, 2024
Public Version Number: 4
DI Record Publish Date: April 18, 2019