| Primary Device ID | D972AMC1616LNATLGST0 |
| NIH Device Record Key | 2cbdc1c1-4e98-4e97-a3a5-66c0e71ac93d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Archwire |
| Version Model Number | AMC1616LNATLGST |
| 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 |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com | |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com | |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com | |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com | |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com | |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com | |
| Phone | 8602241349 |
| acmecorp@acmemonaco.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D972AMC1616LNATLGST0 [Unit of Use] |
| HIBCC | D972AMC1616LNATLGST2 [Primary] |
| DZC | Wire, Orthodontic |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-04-16 |
| Device Publish Date | 2024-04-08 |
| 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 |