AccessGUDID - DEVICE: Excilon (10884521135338)

GUDID

Device Identifier (DI) Information

Brand Name: Excilon
Version or Model: 7084AMD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 7084AMD
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521135338
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 2
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: AMD Antimicrobial Non-woven Sponges,6 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?
48129	Gauze strip, antimicrobial	A thin length of woven material (e.g., cotton, cellulose) that is impregnated with an antimicrobial agent (e.g., iodoform) and primarily designed to pack draining wounds to absorb exudates. It may be soaked with other medication (not included) before application. 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: Yes
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
Width: 4 Inch
Length: 4 Inch

Device Record Status

Public Device Record Key: 6ca066c2-bd96-4fe0-9e10-ed6bfcde1f0f
Public Version Date: January 17, 2025
Public Version Number: 5
DI Record Publish Date: June 30, 2018

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
30884521135332	600	10884521135338	2025-12-31	In Commercial Distribution	CASE
20884521135335	50	10884521135338	2025-12-31	In Commercial Distribution	PACK_OR_INNER_PACK