A+Wedge® GWAK4

GUDID 00810038095684

Complete Wedge Assorted Kit: 200 Count (50 of Each Size)

GARRISON DENTAL SOLUTIONS, L.L.C.

Dental wedge, single-use

• Primary Device ID: 00810038095684
• NIH Device Record Key: dfb1c062-4d5d-40e2-a65f-458dab7e5238
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: A+Wedge®
• Version Model Number: GWAK4
• Catalog Number: GWAK4
• Company DUNS: 057647005
• Company Name: GARRISON DENTAL SOLUTIONS, L.L.C.
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com
• Phone: 888-437-0032
• Email: gds@garrisondental.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810038095684 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140144

FDA Product Code

• EJB: Handle, Instrument, Dental

Sterilization

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

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

[00810038095684]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-05-04
• Device Publish Date: 2020-04-24

On-Brand Devices [A+Wedge®]

• 00810038092997: Wedge Refill, Large, Green
• 00810038092980: Wedge Refill, Medium, Orange
• 00810038092973: Wedge Refill, Small, Blue
• 00810038092966: Wedge Refill, X-Small, Yellow
• 00810038095707: Wedge Assortment Sample Kit: 100 Count (25 of Each Size)
• 00810038095691: Wedge Sample Kit: 50 Count (25) X-Small Yellow, (25) Small Blue
• 00810038095684: Complete Wedge Assorted Kit: 200 Count (50 of Each Size)