Straight Wire

GUDID D97273L00219252

BETA-TITAN 19X25 14"

Acme Monaco Corporation

Orthodontic archwire

• Primary Device ID: D97273L00219252
• NIH Device Record Key: d2078f8f-9b80-47e7-8ee7-3100b8d7239f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Straight Wire
• Version Model Number: 73-L002-1925
• Company DUNS: 118370238
• Company Name: Acme Monaco Corporation
• 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: 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
• 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	D97273L00219250 [Unit of Use]
HIBCC	D97273L00219252 [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: 2024-08-01
• Device Publish Date: 2024-07-24

On-Brand Devices [Straight Wire]

• D972AMC151X31410TRM1: 0155 1X3 TWIST S&C 14" S/S ST 10/TUBE
• D972AMCFLX60ZG1: Flattened Multistrand Wire/Soft (60" on #3 Bobbin)
• D972AMCFLX06ZA1: Flattened Multistrand Wire cut to 6.00±.125" length.
• D972AMC40SC14ST25T2D1: 040 S&C 14" S/S ST 25/TUBE
• D972AMC36SC14ST25T6U1: 036 S&C 14" S/S ST 25/TUBE
• D972AMC32SC14ST25T38: 032 S&C 14" S/S ST 25/TUBE
• D972AMC30SC14ST25TZB1: 030 S&C 14" S/S ST 25/TUBE
• D972AMC28SC14ST25T7P1: 028 S&C 14" S/S ST 25/TUBE
• D972AMC215COAX30JJ1: 0215 COAX 30'/#3BOBBIN
• D972AMC215COAX1410TDZ1: 0215 Staight and Cut 14" Coax S/S ST 10/Tube
• D972AMC195COAX30NK1: 0195 COAX 30'/#3 BOBBIN
• D972AMC195COAX1410TLL1: 0195 S&C 14" COAX S/S ST10/TUBE
• D972AMC1951X31410T9M1: 0195 1X3 TWIST S&C 14" S/S ST 10/TUBE
• D972AMC192514ST10T87: 19X25 S&C 14" S/S ST 10/TUBE
• D972AMC18SC14ST25T6Q1: 018 S&C 14" S/S ST 25/TUBE
• D972AMC182514ST10T7A1: 18X25 S&C 14" S/S ST 10/TUBE
• D972AMC175COAX30MD1: 0175 COAX 30'/ BOBBIN
• D972AMC175COAX1410TJN1: 0175 S&C 14" COAX S/S ST10/TUBE
• D972AMC1751X31410T7T1: 0175 1X3 TWIST S&C 14" S/S ST 10/TUBE
• D972AMC172514ST10T6D1: 17X25 S&C 14" S/S ST 10/TUBE
• D972AMC16SC14ST25T4W2: 016 S&C 14" S/S ST 25/TUBE
• D972AMC162214ST10T3P1: 16X22 S&C 14" S/S ST 10/TUBE
• D972AMC155COAX30L7: 0155 COAX 30'/BOBBIN
• D972AMC155COAX1410TGQ1: 0155 S&C 14" COAX S/S ST10/TUBE
• D972AMC30SC14ST98: 030 S&C 14" S/S ST
• D972AMC28SSBCLASP100B91: 028 S/S BALL CLASP .050" Ball Dia/1.560" Length 100/Bag
• D972AMC2125UOF3SS4T1: 21X25 Upr Orthoform III ST S/S
• D972AMC1815FTK5: 018 NITI WOUND 15'/#3 BOBBIN
• D972AMC1615FTJF1: 016 NITI WOUND 15'/#3 BOBBIN
• D972AMC1415FTHR1: 014 NITI WOUND 15'/#3 BOBBIN
• D972AMC1215FTH3: 012 NITI WOUND 15'/#3 BOBBIN
• D972AMC10X30X365F1: 10X30 OPEN S/S SPRING 36"/#3 BOBBIN
• D972AMC1030NTI153TL1: 10X30 OPEN NITI SPRING 15"/ #3 BOBBIN
• D972AMC36SS075BCLP10021: 036 S/S BALL CLASP .075" Ball Dia/1.560" Length 100/Bag
• D972AMC32SS063BCLP100T6: 032 S/S BALL CLASP .063" Ball Dia/1.560" Length 100/Bag
• D972AMC103021OPN0: 10X30 OPEN NITI SPRING 21"/#3 BOBBIN
• D972AMC10X30X361: 10X30 OPEN S/S SPRING 36"/#3 BOBBIN
• D972NFSS70: Nickel Free S/S Flattened Multistrand Wire cut to 7.00±.125" length.
• D97273L00219252: BETA-TITAN 19X25 14"
• D97273L00217250: BETA-TITAN 17X25 14" PK10
• D97273L00216222: BETA-TITAN 16X22 14"