ENCHANTED™ SERIES

GUDID 20190886033217

ENCHANTED SER COL 1/4 HV ELAST

G & H Wire Company, Inc.

Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band Orthodontic inter-arch elastic band

• Primary Device ID: 20190886033217
• NIH Device Record Key: c316625b-abc5-496c-a963-b2403199cebe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ENCHANTED™ SERIES
• Version Model Number: 14HVAC
• Company DUNS: 831465641
• Company Name: G & H Wire Company, Inc.
• Device Count: 100
• 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: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com
• Phone: +1 317-346-6655
• Email: orders@ghortho.com

Device Dimensions

• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0
• Lumen/Inner Diameter: 0.25 Inch
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00190886033213 [Unit of Use]
GS1	10190886033210 [Primary]
GS1	20190886033217 [Package]; Contains: 10190886033210; Package: [50 Units]; In Commercial Distribution

FDA Product Code

• ECI: Band, Elastic, 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: 2023-10-17
• Device Publish Date: 2023-10-09

Devices Manufactured by G & H Wire Company, Inc.

• 00190886104401 - VERSA-TIES: 2024-05-07 ASSORTED - VERSA-TIE LIG TIE
• 00190886104418 - VERSA-TIES: 2024-05-07 BLACK - VERSA-TIE LIG TIE
• 00190886104425 - VERSA-TIES: 2024-05-07 CLEAR - VERSA-TIE LIG TIE
• 00190886104432 - VERSA-TIES: 2024-05-07 DEEP SKY BLUE - VERSA-TIE LIG TIE
• 00190886104449 - VERSA-TIES: 2024-05-07 FLUORESCENT ORANGE VERSA-TIE LIG TIE
• 00190886104456 - VERSA-TIES: 2024-05-07 FLUORESCENT PINK VERSA-TIE LIG TIE
• 00190886104463 - VERSA-TIES: 2024-05-07 FUCHSIA - VERSA-TIE LIG TIE
• 00190886104470 - VERSA-TIES: 2024-05-07 GLOW BLUE - VERSA-TIE LIG TIE