AccessGUDID - DEVICE: Henry Schein (00304040002179)

GUDID

Device Identifier (DI) Information

Brand Name: Henry Schein
Version or Model: 9009706
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 9009706
Company Name: HENRY SCHEIN, INC.

Primary DI Number: 00304040002179
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 012430880 *Terms of Use

Device Description: Zirlux ST1 95x14mm Disc

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

GMDN

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

GMDN Preferred Term Name	GMDN Definition
Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

GMDN Preferred Term Name

GMDN Definition

Dental appliance fabrication material, ceramic

A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

FDA Product Code

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Product Code	Product Code Name
EIH	POWDER, PORCELAIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K141724	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

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Storage and Handling
Special Storage Condition, Specify: Dry storage space
Storage Environment Temperature: between 0 and 30 Degrees Celsius

Clinically Relevant Size

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Size Type Text
Outer Diameter: 95 Millimeter

Device Record Status

Public Device Record Key: 276975bb-55fd-473a-add5-6e92b7e04c9c
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: September 24, 2016