AccessGUDID - DEVICE: AUVON (06971292005025)

GUDID

Device Identifier (DI) Information

Brand Name: AUVON
Version or Model: SSC-100Q
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Shenzhen Yuwen E-Commerce Co., Ltd.

Primary DI Number: 06971292005025
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 544559614 *Terms of Use

Device Description: It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.

Device Characteristics

What MRI safety information does the labeling contain?	MR Safe
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:	Yes
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: 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: 8b76c2d0-9cb1-4c43-960f-c735ba02cb34
Public Version Date: July 04, 2024
Public Version Number: 1
DI Record Publish Date: June 26, 2024