NEOSMILE

GUDID 10190886139721

NEOSMILE, NON-EXTR. SOFT 42MM

G & H Wire Company, Inc.

Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer Orthodontic retainer

• Primary Device ID: 10190886139721
• NIH Device Record Key: 22ac73ce-3311-4a93-bc57-6c1e8b7f6c52
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NEOSMILE
• Version Model Number: PFTPS042
• Company DUNS: 831465641
• Company Name: G & H Wire Company, Inc.
• Device Count: 1
• 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: false
• 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: +1 317-346-6655
• 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 Identifiers

Device Issuing Agency	Device ID
GS1	10190886139721 [Primary]

FDA Product Code

• KMY: Positioner, Tooth, Preformed

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