AccessGUDID - DEVICE: CONVERTORS (50885380138308)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 45319MNS
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 45319MNS
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380138308
Issuing Agency: GS1
Commercial Distribution End Date: September 07, 2021
Device Count: 6
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: Urological Surgical Drape

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?
42559	Urological surgical drape	A protective covering made of natural or synthetic materials, or both, designed to isolate a urological procedure site from contamination (e.g., microbial, substance). It will typically be shaped for this purpose and may be used for cystoscopy, transurethral resection (TUR), or percutaneous nephrostolithotomy (PCNL). This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
EYY	Drape, urological, disposable

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: 8c98ebb4-d9b7-46f6-8a59-20aee51abd8d
Public Version Date: September 07, 2021
Public Version Number: 2
DI Record Publish Date: August 21, 2018