AccessGUDID - DEVICE: Curity (10884521154063)

GUDID

Device Identifier (DI) Information

Brand Name: Curity
Version or Model: 2146AMD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2146AMD
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521154063
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 200
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: AMD Antimicrobial Gauze Sponges,8 Ply, 0.2% Polyhexamethylene Biguanide HCI (PHMB)

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?
46854	Wound-nonadherent dressing, absorbent, non-antimicrobial	A wound covering typically in the form of a multi-layered pad having a material or substance on its skin-contact surface (e.g., silicone gel), or designed to be soaked in saline prior to application, to prevent adherence to the wound bed thereby decreasing wound trauma potential; it does not contain an antimicrobial agent. It is typically used to absorb wound blood/exudates while protecting the wound from external contamination and maintaining a moist internal environment. It may be used as a primary or secondary dressing to treat chronic and postoperative wounds, burns, ulcers, abrasions, cuts, or puncture sites; it is not a dedicated burn dressing. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FRO	Dressing, Wound, Drug

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: 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: 2 Inch
Width: 2 Inch

Device Record Status

Public Device Record Key: f1a661bb-d0dc-4078-91c1-65a2a53ec88d
Public Version Date: January 17, 2025
Public Version Number: 5
DI Record Publish Date: June 29, 2018