AccessGUDID - DEVICE: Oasis (B031SHARP4G0)

GUDID

Device Identifier (DI) Information

Brand Name: Oasis
Version or Model: SHARP-4G
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: American Health Service Sales Corporation

Primary DI Number: B031SHARP4G0
Issuing Agency: HIBCC
Commercial Distribution End Date: June 11, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 556115970 *Terms of Use

Device Description: SHARPS CONTAINER, 4 GALLON

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 [?]
K101567	000

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 314d2678-0a84-4e78-be1d-a9c7378bd87a
Public Version Date: June 12, 2025
Public Version Number: 3
DI Record Publish Date: December 21, 2018