AccessGUDID - DEVICE: CONVERTORS (50885380132535)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 390270NA
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 390270NA
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380132535
Issuing Agency: GS1
Commercial Distribution End Date: June 19, 2021
Device Count: 600
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Gown, LG, W/Towel In Sterile Wrap, 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?
35091	Surgical gown, single-use	A garment intended to be worn by healthcare staff over a scrub suit to cover the arms, trunk, and upper legs, during a surgical procedure; it may be fluid resistant or impervious to fluids. Also known as an operating room (OR) gown, it is used during surgical procedures to help protect both the patient and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. This is a single-use garment.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FYA	GOWN, SURGICAL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No 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: 24421cbe-4044-4303-b612-627fb92ee411
Public Version Date: June 21, 2021
Public Version Number: 7
DI Record Publish Date: September 14, 2016