Henry Schein 9011047

GUDID 00304040013243

Zirlux 16+ B2 98.5X12

HENRY SCHEIN, INC.

Dental appliance fabrication material, ceramic

• Primary Device ID: 00304040013243
• NIH Device Record Key: 30afcc58-da2a-49cd-a7dc-a3faa4ca19f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Henry Schein
• Version Model Number: 9011047
• Catalog Number: 9011047
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Dimensions

• Outer Diameter: 98.5 Millimeter

Operating and Storage Conditions

• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius
• Storage Environment Temperature: Between 0 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040013243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K141724

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-04
• Device Publish Date: 2016-09-24

On-Brand Devices [Henry Schein]

• 10304040061982: Topical Skin Adh Flex w/Tips
• 10304040057107: Skin Staple Remover with Gauze Sponge
• 10304040057091: Suture Removal Kit
• 10304040057053: Suture Removal Kit with PVP
• 10304040054304: CU1000 Halogen Curing Light
• 10304040054267: Essentials LED Curing Light, Silver
• 10304040054250: Essentials LED Curing Light, Black
• 10304040054243: Essentials LED Curing Light
• 10304040053222: Stadiometer
• 00304040053218: Digital Remote Indicator Scale 500 lb capacity
• 00304040053201: Digital Hand Rail Scale with Height Rod, 1000lb capacity
• 00304040053171: Digital Wheelchair Scale 1,000 lb capacity
• 10304040040611: Sharps Container 5 Quart
• 10304040039769: Suture PGA Undyed DS24
• 10304040039752: Suture PGA Undyed PGA T
• 10304040039721: Suture Chromic Gut DSM19
• 10304040039714: Suture Polysyn PGA FA C-3
• 10304040039707: Suture Chromic Gut C-3
• 10304040039691: Suture Polysyn PGA Violet C-6
• 10304040039684: Suture Polysyn PGA FA C-3
• 10304040039608: Suture PGA PCL Mono DSM13
• 10304040039592: Suture PGA PCL Mono DSM13
• 10304040039585: Suture PGA PCL Mono DSM24
• 10304040039578: Suture PGA PCL Mono DSM13
• 10304040039561: Suture PGL PCL Mono DSM19
• 10304040039554: Suture PGA PCL Mono DSM19
• 10304040039523: Suture Chromic Gut Bge T
• 00304040039519: CENTRIFUGE MIRCROHEMATOCR
• 00304040039489: Acclean Dental Floss Threader
• 10304040039479: Bur Block Plastic 8 Hole
• 10304040039462: Bur Block Plastic 14 Hole
• 10304040039455: Bur Block Plastic 8 Hole
• 10304040039448: Bur Block Plastic 8 Hole
• 10304040039431: Bur Block Plastic 14 Hole
• 10304040039424: Bur Block Plastic 14 Hole
• 10304040039417: Bur Block Magnetic 8 Hole
• 10304040039400: Bur Block Magnetic 14 Hole
• 10304040039394: Bur Block Magnetic 8 Hole
• 10304040039387: Bur Block Magnetic 14 Hole
• 10304040039370: Bur Block Magnetic 8 Hole
• 10304040039363: Bur Block Magnetic 14 Hole
• 00304040037089: Calcium Hydroxide Temporary Root Filling Material
• 10304040036041: Topical Skin Adh Flex w/Tip
• 10304040026547: Sharps Container, 8 Gallon Red
• 10304040026530: Sharps Container 1 Gallon Red
• 10304040026523: Sharps Container 1 Gallon Red
• 10304040026516: Sharps Container 2Gal Red
• 10304040026509: Sharps Collector Phlebotomy
• 00304040023976: Zirlux Temp PMMA 100x20mm
• 00304040023969: Zirlux Temp PMMA 71x20mm