AccessGUDID - DEVICE: Dermacea (10884527021086)

GUDID

Device Identifier (DI) Information

Brand Name: Dermacea
Version or Model: 441605
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 441605
Company Name: Cardinal Health, Inc.

Primary DI Number: 10884527021086
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2025
Device Count: 100
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: X-Ray Sponges,16 Ply

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?
38496	Radiopaque woven surgical sponge	A non-medicated device made from woven gauze (e.g., cotton, cellulose) primarily intended to be used inside the body, on a surgical incision or applied to internal organs or structures to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination during a procedure; also referred to as a laparotomy sponge, it may also be used for prepping the patient. It contains an x-ray detectable marker [e.g., a thread or strand(s)] to help detect gossypiboma (sponge left inside patient). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GDY	GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

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: 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: 8 Inch
Width: 4 Inch

Device Record Status

Public Device Record Key: 066d9c77-b447-4491-ac3a-22765430b386
Public Version Date: November 07, 2024
Public Version Number: 4
DI Record Publish Date: June 27, 2018