AccessGUDID - DEVICE: CONVERTORS (50885380054318)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 42093TNS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 42093TNS
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380054318
Issuing Agency: GS1
Commercial Distribution End Date: January 24, 2021
Device Count: 6
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Ear Drape 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?
39230	ENT surgical drape	A protective covering made of natural or synthetic materials, or both, designed to isolate a surgical site from contamination (e.g., microbial, substance) during an ear/nose/throat (ENT) procedure. It will typically be shaped for this purpose. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
ERY	Drape, surgical, ent

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: dd69cf90-c164-47d0-8cad-b4b0dfe475ad
Public Version Date: January 25, 2021
Public Version Number: 4
DI Record Publish Date: June 21, 2016