AccessGUDID - DEVICE: Steri-Endo Guard Green (00840161301321)

GUDID

Device Identifier (DI) Information

Brand Name: Steri-Endo Guard Green
Version or Model: 50Z452D
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ZIRC DENTAL PRODUCTS, INC.

Primary DI Number: 00840161301321
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 064783913 *Terms of Use
Previous DI: D68550Z452D0

Device Description: "Holds most lengths for staging, cleaning, sterilizing files and reamers Millimeter gauge measures files and positions rubber stopper Right or left hand use Single foam insert cleans and holds files Sterilization counter on locking bar tracks the number of times instruments have been sterilized Organizes up to 11 Engine and 5 Hand files Dimensions: 5-3/8"" x 3/8"" x 2-3/16"" Autoclavable up to 136°C/275°F 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?
16349	Instrument transport trolley system	A combination of carts and/or portable containers designed for safe storage, handling, and transportation of reusable clinical instruments (typically endoscopes or surgical instruments) between the operating and central sterilization rooms. It typically consists of an instrument trolley (cart) with containers; smaller systems may consist of portable closed trays or boxes with gasket seals and/or filters.	Obsolete	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: 136.5 Millimeter
Width: 9.5 Millimeter
Height: 55.6 Millimeter

Device Record Status

Public Device Record Key: 62423610-777e-4fd9-b1bc-1771f84f8bcd
Public Version Date: October 13, 2022
Public Version Number: 1
DI Record Publish Date: October 05, 2022