CoDiagnostiX 010.4030
GUDID 07630031755537
Surgical Guide with cut profile, 3D printed
Institut Straumann AG
Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide Custom-made orthopaedic/craniofacial surgical guide| Primary Device ID | 07630031755537 |
| NIH Device Record Key | ba7e7395-e859-4e18-88ae-31696cc117a3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CoDiagnostiX |
| Version Model Number | Anatomic drill guides |
| Catalog Number | 010.4030 |
| Company DUNS | 483599259 |
| Company Name | Institut Straumann AG |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| 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 | true |
| Manufacturing Date | true |
| 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 | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com | |
| Phone | +1(800)448-8168 |
| info.usa@straumann.com |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630031755537 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K193301
FDA Product Code
| DZJ | DRIVER, WIRE, AND BONE DRILL, MANUAL |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
[07630031755537]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-05-09 |
| Device Publish Date | 2022-04-29 |
Devices Manufactured by Institut Straumann AG
| 07630031764713 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 BLC Implant, Ø 6.5mm WB, SLActive 16mm, Roxolid |
| 07630031765710 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 5.5mm WT, SLActive 14mm, Roxolid |
| 07630031765727 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 5.5mm WT, SLActive 16mm, Roxolid |
| 07630031765741 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 8mm, Roxolid |
| 07630031765758 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 10mm, Roxolid |
| 07630031765765 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 12mm, Roxolid |
| 07630031765772 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 14mm, Roxolid |
| 07630031765789 - Straumann® BLC and TLC Implants - Line extension | 2024-05-13 TLC S Implant, Ø 6.5mm WT, SLActive 16mm, Roxolid |
Trademark Results [CoDiagnostiX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 CODIAGNOSTIX 79098308 4173483 Live/Registered |
Straumann Holding AG 2011-04-29 |
 CODIAGNOSTIX 77263320 not registered Dead/Abandoned |
Anton Josef Voitik 2007-08-24 |
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