STAINLESS STEEL 79-A2U0-1616

GUDID D78879A2U016160

SS RC FORM A 16X16 U

Gc Orthodontics America Inc.

Orthodontic archwire

• Primary Device ID: D78879A2U016160
• NIH Device Record Key: 7d79675f-5ebd-4be6-afc9-cdae67090650
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAINLESS STEEL
• Version Model Number: 79-A2U0-1616
• Catalog Number: 79-A2U0-1616
• 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	D78879A2U016160 [Unit of Use]
HIBCC	D78879A2U016161 [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: 2020-09-16
• Device Publish Date: 2020-09-08

On-Brand Devices [STAINLESS STEEL]

• D78879A2U018250: SS RC FORM A 18X25 U
• D78879A2U016160: SS RC FORM A 16X16 U
• D78879A2L018250: SS RC FORM A 18X25L
• D78878L20000320: SS LAB WIRE .032" 14"
• D78878E4U017250: SS 17X25 UPR STD HI-T
• D78878A32M19250: SS 1925 POSTED 32MM (SP)
• D78878A40M19250: SS 1925 Posted 40mm
• D78878A38M19250: SS 1925 POSTED 38MM (SP)
• D78878A30M19250: SS 1925 POSTED 30MM (SP)
• D78878A2U017220: SS REGULAR FORM A 17X22U
• D78878A2L017220: SS REGULAR FORM A 17X22 L
• D78878A3U019250: SS ST Form A 019x25 U Gold Tone
• E53578A3L019250: SS ST Form A 019x25 L Gold Tone
• E53578A3L017250: SS ST Form A 017x25 L Gold Tone
• D78866021200150: Surgical Ball Hook .022 Pack of 10
• D78866021100150: Surgical Ball Hook .018 Pack of 10
• E53578AQU019250: SS QUAD FLEX FORM A UPPER 19X25
• E53578AQU017250: SS QUAD FLEX FORM A .017 x .025 Mandibul
• E53578AQU016220: SS QUAD FLEX FORM A .016x.022 Mandibular
• E53578AQL019250: SS QUAD FLEX FORM A LOWER 19x25
• E53578AQL017250: SS QUAD FLEX FORM A .017 x .025 Maxillar
• E53578AQL016220: SS QUAD FLEX FORM A .016x.022 Maxillary
• E53578A3U021280: SS ST FORM A 21 x 28 U GOLD TONE
• E53578A3U018250: SS ST FORM A 18 x 25 U GOLD TONE
• E53578A3U016220: SS ST FORM A 16 x 22 U GOLD TONE
• E53578A3L021280: SS ST FORM A 21 x 28 L GOLD TONE
• E53578A3L018250: SS ST FORM A 18 x 25 L GOLD TONE
• E53578A3L016220: SS ST FORM A 16 x 22 L GOLD TONE
• E53578C4U016220: SS HT FORM C 16 x 22 UPPER GOLD TONE
• E53578C4L016220: SS HT FORM C 16 x 22 LOWER GOLD TONE