AccessGUDID - DEVICE: SharpSafety (40884521022714)

GUDID

Device Identifier (DI) Information

Brand Name: SharpSafety
Version or Model: 85321
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 85321
Company Name: Cardinal Health, Inc.

Primary DI Number: 40884521022714
Issuing Agency: GS1
Commercial Distribution End Date: December 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 080935429 *Terms of Use

Device Description: In Room Sharps Container,Always Open Lid, Clear

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?
35429	Sharps container	A hard-walled container designed for the safe deposit and collection of biologically or chemically contaminated used sharps; this includes needles, lancets, scalpel blades, cannulae, or other devices that present a hazard to a healthcare worker or patient if they were to inadvertently have bodily contact with the device and cause themselves an injury. This container is typically designed to be puncture resistant, leak-proof, and closable (usually having a lid that cannot be reopened once closed) and is identified with the universal biohazard symbol on its labelling. It is disposed of when filled to the recommended level, typically by incineration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MMK	Container, sharps

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: ;

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Gallon

Device Record Status

Public Device Record Key: 6cd7ef2f-650c-4587-9a4b-cffde3de6853
Public Version Date: January 01, 2024
Public Version Number: 10
DI Record Publish Date: September 24, 2016