Identity
- Trade Name
- Clarus Digital Inspection Scope, 1.9mm OD FDA UDI
- Generic Name
- Instrument inspection scope FDA UDI
- Device Name
- The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The device includes an image sensor chip to convey images. This is a reusable device. FDA UDI
- Model / Reference
- CD2-1100 FDA UDI
- Description
- The Clarus Inspection Scope is a device with a flexible working length intended for the visual examination of the lumen of an instrument (typically an endoscope) to identify any dirt/debris within the lumen so that it can be removed prior to disinfection/sterilization; it is not intended for patient examination. The device includes an image sensor chip to convey images. This is a reusable device. FDA UDI
Identifiers
- Catalog Number
- CD2-1100 FDA UDI
- Primary DI / UDI-DI
- 10810004820002 FDA UDI
- FDA Product Code
- MNL FDA UDI
- GMDN Term
- Instrument inspection scope FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.1500 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Instrument inspection scope
Clarus Digital Inspection Scope, 1.9mm OD by Clarus Medical, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Instrument inspection scope.
- Clarus Inspection Scope, Mini — CLARUS MEDICAL, LLC · Class I
- Clarus Digital Inspection Scope, Long — CLARUS MEDICAL, LLC · Class I
- Clarus Digital Inspection Scope, 1mm x 110cm, High Definition — CLARUS MEDICAL, LLC · Class I
- Clarus Inspection Scope, Long — CLARUS MEDICAL, LLC · Class I
- Clarus Inspection Scope, Mini, Short — CLARUS MEDICAL, LLC · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clarus Medical, Llc
Sources (1)
- FDA UDI 31f3489f-baee-4d33-a1ce-3786592b4dee 35 fields · synced May 30, 2026