AccessGUDID - DEVICE: CONVERTORS (50885380003781)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 8337N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8337N
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380003781
Issuing Agency: GS1
Commercial Distribution End Date: November 10, 2020
Device Count: 2850
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Mayo Stand 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":	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?
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
KKX	Drape, surgical

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: 30b7ff38-e9aa-41c5-9e53-2328610fca07
Public Version Date: November 10, 2020
Public Version Number: 5
DI Record Publish Date: June 21, 2016