AccessGUDID - DEVICE: Curity (10884521138124)

GUDID

Device Identifier (DI) Information

Brand Name: Curity
Version or Model: 8042AMD
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 8042AMD
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884521138124
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,4 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?
13701	Germicidal sponge	A device impregnated with an antimicrobial agent and intended to be applied to a surgical incision, other skin wound, or an internal structure to control bleeding, absorb fluid, and to protect against contamination. 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: ;

Clinically Relevant Size

[?]

Size Type Text
Width: 2 Inch
Length: 2 Inch

Device Record Status

Public Device Record Key: 05f185c3-41d4-459e-ad6f-397a5985161c
Public Version Date: January 17, 2025
Public Version Number: 4
DI Record Publish Date: June 27, 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
20884521138121	50	10884521138124	2025-12-31	In Commercial Distribution	PACK_OR_INNER_PACK
30884521138128	3000	10884521138124	2025-12-31	In Commercial Distribution	CASE