AccessGUDID - DEVICE: CARDINAL HEALTH (20885380053303)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: C-NXR4412
Commercial Distribution Status: In Commercial Distribution
Catalog Number: C-NXR4412
Company Name: Cardinal Health 200, LLC

Primary DI Number: 20885380053303
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 200
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: X-Ray Detectable Sponges 4 x 4in. (10.2 x 10.2cm) CAUTION: For External Use Only. 12-Ply Woven 100 percent Cotton with Wavy Barium Sulfate Band. Non Sterile. Single Use Only. Not Made with Natural Rubber Latex. Store in a Cool, Dry Place.

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":	Yes
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?
58802	Radiopaque woven surgical sponge, non-sterile	A non-medicated non-sterile 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 intended to be sterilized prior to use.	Obsolete	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: No
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: 911e4524-3006-4646-a10d-8f49fffd2075
Public Version Date: June 27, 2019
Public Version Number: 1
DI Record Publish Date: June 19, 2019