AccessGUDID - DEVICE: Steri-Container Neon Pink (00840161300799)

GUDID

Device Identifier (DI) Information

Brand Name: Steri-Container Neon Pink
Version or Model: 50Z900S
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161300799
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use
Previous DI: D68550Z900S0

Device Description: "Used to contain instruments during ultrasonic and sterilization procedures Durable, self-lubricating plastic with a securely snapping lid Dimensions: 8-1/8"" x 1-7/8"" x 1-7/8"" Contains Antimicrobial Protection Autoclavable up to 136°C/275F° Washer-disinfect"

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:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
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?
42893	General-purpose bowl, reusable	A portable bowl or basin designed to be used for a variety of medical purposes such as containing fluids, carrying or holding instruments prior to or during a procedure, and collecting body waste or other matter. The design and shape can vary including round, oblong, deep or quite shallow. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
FSM	Tray, Surgical, Instrument

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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
Length: 206 Millimeter
Width: 48 Millimeter
Height: 48 Millimeter

Device Record Status

Public Device Record Key: 52b585d2-e63a-489d-9c0d-141615eacb33
Public Version Date: October 13, 2022
Public Version Number: 1
DI Record Publish Date: October 05, 2022