| Primary Device ID | D788GCO10001 | 
| NIH Device Record Key | 4a86532c-8b2f-46b4-a62a-50adb1d86aa2 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | EXCALIBUR | 
| Version Model Number | GCO-1000 | 
| Catalog Number | GCO-1000 | 
| 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 | D788GCO10001 [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 |