AccessGUDID - DEVICE: CARDINAL HEALTH (20885380133845)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: C-SG4416S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: C-SG4416S
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20885380133845
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2022
Device Count: 10
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: -Premium Gauze Sponges -4 x 4 in (10.2 x 10.2 cm) -16-Ply -USP Type VII Gauze

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?
44971	General-purpose surgical sponge	A non-medicated cushion-like mass made of absorbent materials (e.g., woven gauze, 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 or cottonoid pad/pattie, it may also be used for prepping the patient. It does not contain special features to help detect gossypiboma (sponge left inside patient) [i.e., it is not radiopaque]. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
NAB	Gauze / sponge,nonresorbable for external use

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: 70d4c07b-c423-4344-8133-a28529d2db0a
Public Version Date: January 02, 2023
Public Version Number: 4
DI Record Publish Date: September 11, 2019