BIO-ACTIVE 74-A0U0-1825

GUDID E53574A0U018250

BIO-ACTIVE RC U FORM A 18X25

Gc Orthodontics America Inc.

Orthodontic archwire

• Primary Device ID: E53574A0U018250
• NIH Device Record Key: 311459d2-17db-4c13-a672-bc3fb1b9e095
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BIO-ACTIVE
• Version Model Number: 74-A0U0-1825
• Catalog Number: 74-A0U0-1825
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	E53574A0U018250 [Unit of Use]
HIBCC	E53574A0U018251 [Primary]

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: 2021-09-03
• Device Publish Date: 2021-08-26

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