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CoDiagnostiX

FDA UDI

Class II (US FDA UDI)

by Institut Straumann SA

Identity

Trade Name
CoDiagnostiX FDA UDI
Generic Name
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Surgical Guide with cut profile, 3D printed FDA UDI
Model / Reference
Anatomic drill guides FDA UDI
Description
Surgical Guide with cut profile, 3D printed FDA UDI

Identifiers

Catalog Number
010.4030 FDA UDI
Primary DI / UDI-DI
07630031755537 FDA UDI
510(k) Number
K193301 FDA UDI
FDA Product Code
DZJ FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
872.4120 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Custom-made orthopaedic/craniofacial surgical guide

CoDiagnostiX by Institut Straumann SA — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Institut Straumann SA

Sources (1)

  • FDA UDI ba7e7395-e859-4e18-88ae-31696cc117a3 37 fields · synced May 29, 2026