BIO-ACTIVE 70-A1L0-2218

GUDID D7887A1L022180

BIO-ACTIVE FORM A 22X18 LWR

Gc Orthodontics America Inc.

Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire Orthodontic archwire

• Primary Device ID: D7887A1L022180
• NIH Device Record Key: 4696c672-2f9e-458d-9126-82326ee41d5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-ACTIVE
• Version Model Number: 70-A1L0-2218
• Catalog Number: 70-A1L0-2218
• Company DUNS: 063167128
• Company Name: Gc Orthodontics America Inc.
• Device Count: 10
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com
• Phone: +1(708)897-8859
• Email: GCOAInfo@gcorthodontics.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D78870A1L022181 [Primary]
HIBCC	D7887A1L022180 [Unit of Use]

FDA Product Code

• DZC: WIRE, ORTHODONTIC

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: 2020-09-16
• Device Publish Date: 2020-09-08

On-Brand Devices [BIO-ACTIVE]

• D78874B0U018250: BIO-ACTIVE RC U FORM B 18X25
• D78870A1U022180: BIO-ACTIVWE FORM A 21/18 UPR
• D7887A1L022180: BIO-ACTIVE FORM A 22X18 LWR
• E53574A0U018250: BIO-ACTIVE RC U FORM A 18X25
• E53574A0L018250: BIO-ACTIVE RC L FORM A 18X25
• E53570D10020200: BIO-ACTIVE FORM D 20X20 LIGHT
• E53570D10019250: BIO-ACTIVE FORM D 19X25 LIGHT
• E53570D10018250: BIO-ACTIVE FORM D 18X25 LIGHT
• E53570D10018180: BIO-ACTIVE FORM D 18X18 LIGHT
• E53570D10017250: BIO-ACTIVE FORM D 17X LIGHT
• E53570D10016220: BIO-ACTIVE FORM D 16X16 LIGHT
• E53570D10016160: BIO-ACTIVE FORM D 16X16 LIGHT
• E53570D10014250: BIO-ACTIVE FORM D 14X25 LIGHT
• E53570D10000160: BIO-ACTIVE FORM D 016 LIGHT
• E53570D10000140: BIO-ACTIVE FORM D 014 LIGHT
• E53570B0U016160: BIO-ACTIVE FORM B 16X16 U