AccessGUDID - DEVICE: Zirlux (00304040023457)

GUDID

Device Identifier (DI) Information

Brand Name: Zirlux
Version or Model: 9011260
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9011260
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040023457
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: ZIRLUX ACETAL MILLING DISC

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):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name	GMDN Definition
Dental crown/bridge resin, temporary	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

FDA Product Code

[?]

Product Code	Product Code Name
EHP	CLASP, PREFORMED

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: n/a
Storage Environment Temperature: less than 193 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Height: 20 Millimeter

Device Record Status

Public Device Record Key: 0535ad7d-88c2-4cee-8825-f5efc2c9d216
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016