AccessGUDID - DEVICE: CONVERTORS (00630140031611)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 8371CE
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 8371CE
Company Name: Cardinal Health 200, LLC

Primary DI Number: 00630140031611
Issuing Agency: GS1
Commercial Distribution End Date: June 07, 2022
Device Count: 1
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: BACK TABLE COVER 25/CS LATEX GAMMA 140X190CM

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?
47782	Patient surgical drape, single-use, non-sterile	A non-sterile, noninvasive flat sheet designed to cover a portion of a patient’s anatomy during a surgical procedure to isolate a specific anatomical site (e.g., site of surgical incision) from potential contamination (e.g., microbial, substance). The device may also be used to protect a patient from heat/flame during a surgical procedure, however it is not designed with specific heat-reflective or laser resistant materials. This is a single-use device intended to be sterilized prior to use.	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: Yes
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: 67e37985-56f2-4397-8b89-ba7db24ec36b
Public Version Date: June 07, 2022
Public Version Number: 3
DI Record Publish Date: August 13, 2019