Essentials 1126761

GUDID 20304040117204

Essentials EL Procedure Masks

HENRY SCHEIN, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 20304040117204
• NIH Device Record Key: 1562c443-d6c2-4cc5-817d-c3dc60f780ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Essentials
• Version Model Number: 1126761
• Catalog Number: 1126761
• Company DUNS: 012430880
• Company Name: HENRY SCHEIN, INC.
• Device Count: 50
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	00304040117200 [Unit of Use]
GS1	10304040117207 [Primary]
GS1	20304040117204 [Package]; Contains: 10304040117207; Package: Case [6 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K051291

FDA Product Code

• FXX: Mask, surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-05-06
• Device Publish Date: 2019-10-30

On-Brand Devices [Essentials]

• 10304040063542: Essentials MaxPro M Handpiece
• 10304040063528: Essentials MaxPro Handpiece
• 10304040054366: Essentials Compact LED Curing Light
• 10304040019556: Essentials Self Seal Pouch
• 10304040019549: Essentials Self Seal Pouch
• 10304040019532: Essentials Self Seal Pouch
• 10304040019525: Essentials Self Seal Pouch
• 10304040019518: Essentials Self Seal Pouch
• 10304040019501: Essentials Self Seal Pouch
• 10304040019259: Essentials EL Procedure Masks
• 10304040019242: Essentials EL Procedure Masks
• 20304040117211: Essentials EL Procedure Masks
• 20304040117204: Essentials EL Procedure Masks
• 00304040126387: Low Speed Contra Angle Head
• 00304040125656: LED Curing Light
• 00304040125649: LED Curing Light
• 00304040110119: Essentials Pro 2SM Handpiece
• 00304040110102: Essentials Pro 2S Handpiece
• 00304040110096: Essentials Pro 2M Handpiece
• 00304040110089: Essentials Pro 2 Handpiece
• 00304040093368: Essentials Pro S
• 00304040093344: Essentials Pro SM
• 00304040058268: Essentials E-Type Contra Angle
• 00304040058251: Essentials E-Type Straight
• 00304040058244: Essentials 20,000 RPM E-Type
• 00304040058237: Essentials 20,000 RPM E-Type
• 00304040058220: Essentials Mini C-Type Handpc
• 00304040058213: Essentials Mini C-Type PB HP
• 00304040058206: Essentials C-Type Handpiece
• 00304040058190: Essentials C-Type PB Handpiece
• 10304040151461: Essentials Sharps Container 2 Gal
• 10304040151454: Essentials Sharps Container 5 Qt
• 00304040152119: Essentials Cotton Sponge 2"x2" 8ply 5000/ca
• 20304040139015: Essentials Latex Glove
• 20304040139008: Essentials Latex Glove
• 20304040138995: Essentials Latex Glove
• 20304040138988: Essentials Latex Glove
• 20304040138971: Essentials Latex Glove
• 20304040138957: Essentials Vinyl Blue Glove
• 20304040138940: Essentials Vinyl Blue Glove
• 20304040138933: Essentials Vinyl Blue Glove
• 20304040138926: Essentials Vinyl Blue Glove
• 00304040153581: Cotton Sponge 2x2
• 20304040140448: Isolation Gowns AAMI 3 Yellow Large
• 20304040140431: Isolation Gowns AAMI 3 Blue Large
• 20304040140424: Isolation Gowns AAMI 3 Yellow Medium
• 20304040140417: Isolation Gowns AAMI 3 Blue Medium
• 20304040140264: Isolation Gowns AAMI 3 Yellow X-Large
• 20304040140257: Isolation Gowns AAMI 3 Blue X-Large
• 00304040169032: Procedure Mask L3 Blue