Archwire

GUDID D97277G0U218250

NITI REVERSE 18X25 U PK10

Acme Monaco Corporation

Orthodontic archwire

• Primary Device ID: D97277G0U218250
• NIH Device Record Key: d471eff3-13cb-4538-9db9-180ea97153df
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Archwire
• Version Model Number: 77-G0U2-1825
• 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	D97277G0U218250 [Unit of Use]
HIBCC	D97277G0U218252 [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: 2024-09-25
• Device Publish Date: 2024-09-17

On-Brand Devices [Archwire ]

• D972AMC2125UOF3SS14: 21X25 Upr Orthoform III ST S/S
• D972AMC162228MMS43: 16X22 LWR NAT S/S ST 28MM BRASS POST
• D972AMC16UMNAT25E1: 016 UPR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC14UMNAT25EW5: 014 UPR NAT MEDIUM (TRUFORM) S/S ST -25/ENV
• D972AMC14LMNAT25EQS1: 014 LWR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC2125UMNAT25EKF1: 21X25 UPR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC2125LMNAT25EE4: 21X25 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC20UMNAT25EU6: 020 UPR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC20LMNAT25ENT1: 020 LWR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC1925UMNAT25ES2: 19X25 UPR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC1925LMNAT25ELP1: 19X25 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC18UMNAT25EYZ1: 018 UPR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC18RNITI25EZU1: 018 UNIV NITI - 25/ENV
• D972AMC18LMNAT25ETN1: 018 LWR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC1825UMNAT25ER3: 18X25 UPR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC1825LMNAT25EKQ1: 18X25 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC1725UMNAT25EQ4: 17X25 UPR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC1725LMNAT25EJR1: 17X25 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC16RNITI25EYE1: 016 UNIV NITI - 25/ENV
• D972AMC16LMNAT25ES8: 016 LWR NAT MEDIUM (TRUFORM) S/S ST - 25/ENV
• D972AMC1622UMNAT25ELY1: 16X22 UPR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC1622RNITI25EMT1: 16X22 UNIV NITI - 25/ENV
• D972AMC1622LMNAT25EFM1: 16X22 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC162214STQM1: 16X22 S&C 14" S/S ST
• D972AMC1616UMNAT25ENX1: 16X16 UPR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC1616RNITI25EPS1: 16X16 UNIV NITI - 25/ENV
• D972AMC1616LMNAT25EHL1: 16X16 LWR NAT MEDIUM (TRUFORM) S/S ST- 25/ENV
• D972AMC14RNITI25EWY1: 014 UNIV NITI - 25/ENV
• D972AMC1425RNITI25EN2: 14X25 UNIV NITI - 25/ENV
• D972AMC18RST25ELU1: 018 UNIV S/S ST 25/ENV
• D972AMC1825RST25E8E1: 18X25 UNIV S/S ST 25/ENV
• D972AMC1725RST25E7P1: 17X25 UNIV S/S ST 25/ENV
• D972AMC16UMNAT25EXK1: 016 UPR NAT MEDIUM (TRUFORM) S/S ST 25/ENV
• D972AMC16RST25EKS1: 016 UNIV S/S ST 25/ENV
• D972AMC1625RST25E6Y1: 16X25 UNIV S/S ST 25/ENV
• D972AMC1622RST25E5D1: 16X22 UNIV S/S ST 25/ENV
• D972AMC1616RST25E6W1: 16X16 UNIV S/S ST 25/ENV
• D972AMC14RST25EJQ1: 014 UNIV S/S ST 25/ENV
• D972AMC1425RST25E5J1: 14X25 UNIV S/S ST 25/ENV
• D972AMC192538MMS7E1: 19X25 UPR NAT S/S ST 38MM BRASS POST
• D972AMC192536MMS6Y1: 19X25 UPR NAT S/S ST 36MM BRASS POST
• D972AMC192534MMS6J1: 19X25 UPR NAT S/S ST 34MM BRASS POST
• D972AMC192532MMS64: 19X25 UPR NAT S/S ST 32MM BRASS POST
• D972AMC192528MMS73: 19X25 LWR NAT S/S ST 28MM BRASS POST
• D972AMC192526MMS6M1: 19X25 LWR NAT S/S ST 26MM BRASS POST
• D972AMC1622RCLLYN1: 16X22 LWR R/C NITI
• D972AMC162226MMS3M1: 16X22 LWR NAT S/S ST 26MM BRASS POST
• D972AMC1925UNITINR1: 19X25 UPR NAT NITI
• D972AMC1925RCLL3D1: 19X25 LWR R/C NITI
• D972AMC1925LNITIKN1: 19X25 LWR NAT NITI