AccessGUDID - DEVICE: CARDINAL HEALTH (50885380074743)

GUDID

Device Identifier (DI) Information

Brand Name: CARDINAL HEALTH
Version or Model: 43490MNS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 43490MNS
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380074743
Issuing Agency: GS1
Commercial Distribution End Date: March 20, 2021
Device Count: 16
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Mayfield Straddle Table Cover BNS

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?
45021	Instrument/equipment drape, single-use, sterile	A sterile device made of natural and/or synthetic flexible materials intended to be used as a non-dedicated protective covering for various surgical and/or non-surgical instruments/equipment [e.g., surgical tray, operating room (OR) equipment table, endoscope and endoscopic instruments, surgical cameras and lasers], to provide a barrier against cross-contamination in various clinical settings. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
PUI	Drape, surgical, exempt

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: Yes

Sterilization Method [?]
Ethylene Oxide

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: 3e972175-a0ac-405f-bf89-bfbf16905a69
Public Version Date: March 22, 2021
Public Version Number: 5
DI Record Publish Date: June 23, 2016