SM DRYFIELD KIT RED *I 300-400

GUDID D7753004000

SM DRYFIELD KIT RED *I

GREAT LAKES ORTHODONTICS, LTD.

Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable Dental cheek retractor, professional, reusable

• Primary Device ID: D7753004000
• NIH Device Record Key: a05596e2-5d74-4bbe-81b3-655f6b90f1e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SM DRYFIELD KIT RED *I
• Version Model Number: 300-400
• Catalog Number: 300-400
• Company DUNS: 041854332
• Company Name: GREAT LAKES ORTHODONTICS, LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com
• Phone: 800-828-7626
• Email: info@greatlakesortho.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D7753004000 [Primary]

FDA Product Code

• DYN: Mouthpiece, Saliva Ejector

Sterilization

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

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

[D7753004000]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-05
• Device Publish Date: 2016-05-18

Devices Manufactured by GREAT LAKES ORTHODONTICS, LTD.

• D7753004000 - SM DRYFIELD KIT RED *I: 2018-10-05SM DRYFIELD KIT RED *I
• D7753004000 - SM DRYFIELD KIT RED *I: 2018-10-05 SM DRYFIELD KIT RED *I
• D7753004010 - LG DRYFIELD KIT WHITE *I: 2018-10-05 LG DRYFIELD KIT WHITE *I
• D7753004060 - RETRACTOR - LARGE WHITE *I: 2018-10-05 RETRACTOR - LARGE WHITE *I
• D7753004140 - RETRACTOR - SMALL RED *I: 2018-10-05 RETRACTOR - SMALL RED *I
• D7753006120 - LARGE LIP RETRACTOR *O: 2018-10-05 LARGE LIP RETRACTOR *O
• D7753006140 - SMALL LIP RETRACTOR *O: 2018-10-05 SMALL LIP RETRACTOR *O
• D7753006260 - GL INTRAORAL MOUTH PROPS: 2018-10-05 GL INTRAORAL MOUTH PROPS
• D7753006270 - GL INTRAORAL MOUTH PROPS: 2018-10-05 GL INTRAORAL MOUTH PROPS