CoDiagnostiX 010.4030

GUDID 07630031755537

Surgical Guide with cut profile, 3D printed

Institut Straumann AG

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
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: info.usa@straumann.com
• Phone: +1(800)448-8168
• Email: 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

• 07630031771599 - NA: 2025-12-10 BLC Profile Drill, FIBA compatible, Ø 4.0mm, L 26mm, stainless steel
• 07630031774194 - NA: 2025-12-10 Guiding Cylinder for Explantation, SC Ø 2.9mm, stainless steel
• 07630031774200 - NA: 2025-12-10 Guiding Cylinder for Explantation, NC Ø 3.3mm, stainless steel
• 07630031774217 - NA: 2025-12-10 Guiding Cylinder for Explantation, RC Ø 4.1mm, stainless steel
• 07630031774224 - NA: 2025-12-10 Guiding Cylinder for Explantation, RC Ø 4.8mm, stainless steel
• 07630031774231 - NA: 2025-12-10 Explantation Drill, short, for Ø 2.9 - 3.3mm, L 37mm, stainless steel
• 07630031774248 - NA: 2025-12-10 Explantation Drill, short, for Ø 3.5 - 3.75mm, L 37mm, stainless steel
• 07630031774255 - NA: 2025-12-10 Explantation Drill, short, for Ø 4.0 - 4.1mm, L 37mm, stainless steel