Coil

GUDID D972AMC10X30X36C0

UDI World Biotech UDI

Acme Monaco Corporation

Orthodontic archwire

• Primary Device ID: D972AMC10X30X36C0
• NIH Device Record Key: cf2846f1-6699-4f55-b3cc-b75047cafc51
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Coil
• Version Model Number: AMC10X30X36C
• Company DUNS: 118370238
• Company Name: Acme Monaco Corporation
• 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: false
• Serial Number: false
• Manufacturing Date: false
• 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: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D972AMC10X30X36C0 [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: 2024-05-02
• Device Publish Date: 2024-04-24

On-Brand Devices [Coil]

• D972AMC10X30X36C2: SS Closed Coil10x30 / 91 cm
• D972AMC10X30X362: SS Open coil 10x30 /91 cm
• D972AMC10309MME2: NiTi Closed Eyelet Spring - 9 mm - 50 pcs
• D972AMC103021OPN2: NiTi Open Coil 10x30
• D972AMC123021OPN0: 12X30 OPEN NITI SPRING 21"/#3 BOBBIN
• D972AMC10X30X36C0: UDI World Biotech UDI
• D972AMC215COAX300: 0215 COAX 30'/#3 BOBBIN