AccessGUDID - DEVICE: CONVERTORS (50885380018198)

GUDID

Device Identifier (DI) Information

Brand Name: CONVERTORS
Version or Model: 599N
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 599N
Company Name: Cardinal Health 200, LLC

Primary DI Number: 50885380018198
Issuing Agency: GS1
Commercial Distribution End Date: May 16, 2022
Device Count: 7200
Labeler D-U-N-S® Number*: 961027315 *Terms of Use

Device Description: SURGICAL SLEEVE, 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?
62670	Surgical sleeve cover, non-sterile	A non-sterile forearm covering made of non-woven synthetic fabric materials intended to be worn over a scrub suit by healthcare staff during a surgical procedure to maintain hygiene and prevent cross-contamination of microorganisms, body fluids, and particulate material between the patient and staff. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
LYU	ACCESSORY, SURGICAL APPAREL

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: 1a1293f3-23f0-4987-a67b-9e8856d57f0a
Public Version Date: May 16, 2022
Public Version Number: 5
DI Record Publish Date: November 27, 2017