| Primary Device ID | D788GC1016SH1 |
| NIH Device Record Key | 92f436d2-7ff2-4fa9-923d-eb0eb437a151 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | EXCALIBUR |
| Version Model Number | GCO-1016SH |
| Catalog Number | GC1016SH |
| Company DUNS | 063167128 |
| Company Name | Gc Orthodontics America Inc. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com | |
| Phone | +1(708)897-8859 |
| GCOAInfo@gcorthodontics.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D788GC1016SH1 [Primary] |
| DZN | INSTRUMENTS, DENTAL HAND |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-02-07 |
| Device Publish Date | 2022-01-28 |
| D788550FU200001 | TN 3 Instrument |
| D788GCO70011 | WIRE CUTTER |
| D788GCO3471 | POSTERIOR BAND REMOVER |
| D788GCO1581 | WEINGART |
| D788GCO1016U1 | DISTAL END CUTTER |
| D788GCO1016LH1 | DISTAL END CUTTER MINI LONG HANDLE |
| D788GCO1000HWC1 | HARDWIRE CUTTER |
| D788GCO10001 | 15 DEGREE PIN & LIG |
| D788GC1016SH1 | DISTAL END CUTTER MINI LONG HANDLE |
| D788GCO826301 | Distal Thermo Plier |
| D788GCO826201 | Small Circle Forming Plier |
| D788GCO825301 | Mandibular Thermoforming Plier |
| D788GCO825201 | Maxillary Thermoforming Plier |
| D788GCO825101 | Undercut Enchancer Plier |
| D788550FU300001 | BEAVER TAIL |
| D788GCO5151 | SMAHA 515 FORCEP |
| D788GCO346RT1 | GCO-346 RT |
| D788GCO14051 | Narrow Replacement Set for GCO-345 |
| D788GCO880021 | BRACKET POSITIONER |
| D788GCO5101 | Force Module Instrument (ASPEL) |
| D788GCO4001 | Set Roncone Plier |
| D788GCO1391 | Bird Beak Plier |
| D788GCO10021 | Miniature Pin and Ligature Cutter |
| D788GCO10011 | Pin and Ligature Cutter |
| D788112D0400101 | EXC ROTH 022 U 4-4 HK 34 |