Ligature

GUDID D972AMC12LKOBY6

012 LONG KOBY WELD LIGATURE

Acme Monaco Corporation

Orthodontic archwire

• Primary Device ID: D972AMC12LKOBY6
• NIH Device Record Key: 9b8e9d4a-2d90-4591-8363-69d22a3f7fab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Ligature
• Version Model Number: AMC12LKOBY
• Company DUNS: 118370238
• Company Name: Acme Monaco Corporation
• 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: 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
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com
• Phone: 8602241349
• Email: acmecorp@acmemonaco.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D972AMC12LKOBY0 [Unit of Use]
HIBCC	D972AMC12LKOBY6 [Primary]

FDA Product Code

• DZC: Wire, Orthodontic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2022-08-24
• Device Publish Date: 2022-08-01

On-Brand Devices [Ligature]

• D972AMC12ASKOBYF1: 012 FLAT TWISTED KOBY LIGATURE ALMOND
• D972AMC14SKOBY100TND1: 014 FLAT TWISTED KOBY LIGATURE - 100/TUBE
• D972AMC14LKOBY49: 014 LONG KOBY WELD LIGATURE
• D972AMC12SKOBY100TLK1: 012 FLAT TWISTED KOBY LIGATURE 100/TUBE
• D972AMC12LKOBY3F1: 012 LONG KOBY WELD LIGATURE
• D972AMC10LIGMV1: 010 STD PREFORM LIGATURE
• D972AMC10ANGLIG1000TS7: 010 SHORT TWISTED LIGATURE 1,000/TUBE
• D972AMC14SKOBY100T6: 014 FLAT TWISTED KOBY LIGATURE - 100/TUBE
• D972AMC14LKOBY6: 014 LONG KOBY WELD LIGATURE
• D972AMC12SKOBY100T6: 012 FLAT TWISTED KOBY LIGATURE 100/TUBE
• D972AMC12LKOBY6: 012 LONG KOBY WELD LIGATURE
• D972AMC9LIG0: 009 LONG STD PREFORM LIGATURE
• D972AMC10ANGLIG2: Pretwisted Ligature wire .010- 1000pcs
• D972AMC12ASKOBY6: 012 FLAT TWISTED KOBY LIGATURE ALMOND
• D972AMC10LIG8: 010 LONG STD PREFORM LIGATURE
• D972AMC12WTWLIG1: 012 SHORT TWISTED LIGATURE WHITE
• D972AMC12WLIG6: 012 LONG STD PREFORM LIGATURE WHITE
• D972AMC11LIG0: 011 LONG STD PREFORM LIGATURE
• D972AIR12LIG0: 012 LONG STD PREFORM LIGATURE
• D972AMC10ANGLIG500B0: 010 SHORT TWISTED LIGATURE
• D97267022020120: KOBAYSHI 012 TWIST SHORT