SUPERFIT

GUDID 10814639024972

SUPERFIT Disposable Procedural Face masks, Ear Loops. Level II

APPLIED DENTAL, INC.

Surgical/medical face mask, single-use

• Primary Device ID: 10814639024972
• NIH Device Record Key: 9e5d994f-4a84-461a-839e-8256bf03f54e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SUPERFIT
• Version Model Number: FMK-50
• Company DUNS: 017524666
• Company Name: APPLIED DENTAL, INC.
• Device Count: 1
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com
• Phone: 1-888-841-8481
• Email: info.usa@AD-Surgical.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00814639024975 [Primary]
GS1	10814639024972 [Package]; Contains: 00814639024975; Package: Box [50 Units]; In Commercial Distribution
GS1	20814639024979 [Package]; Package: Carton [40 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123115

FDA Product Code

• FXX: Mask, Surgical

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-14
• Device Publish Date: 2020-08-06

On-Brand Devices [SUPERFIT ]

• 10814639024972: SUPERFIT Disposable Procedural Face masks, Ear Loops. Level II
• 10814639024965: SUPERFIT Surgical Disposable Isolation Gown. Level II.
• 10814639023418: SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 8.0.
• 10814639023401: SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 7.5.
• 10814639023395: SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 7.0.
• 10814639023388: SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.5.
• 10814639023371: SUPERFIT Disposable Latex Surgical Gloves. Powder Free. Size 6.0.
• 10814639023265: SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 8.5. Sterile.
• 10814639023241: SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 8.0. Sterile.
• 10814639023234: SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 7.5. Sterile.
• 10814639023210: SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 7.0. Sterile.
• 10814639023203: SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 6.5. Sterile.
• 10814639023180: SUPERFIT Disposable Nitrile Surgical Gloves. Powder Free. Size 6.0. Sterile.