Identity
- Trade Name
- Clear Guide VisiMARKER Non-Sterile FDA UDI
- Generic Name
- Imaging lesion localization marker, external, single-use FDA UDI
- Device Name
- The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. FDA UDI
- Model / Reference
- CGVMNS FDA UDI
- Description
- The device is a sterile or sterilizable (via PVP-I or similar antiseptic) accessory intended to mark a set of locations on a patient's intact, uncompromised skin. The device is also intended to mark objects in the operational field of view. The device is intended to be used in clinical settings, by clinicians familiar with aseptic technique. FDA UDI
Identifiers
- Catalog Number
- CG-VM-NS FDA UDI
- Primary DI / UDI-DI
- B201CGVMNS0 FDA UDI
- FDA Product Code
- JAC FDA UDI
- GMDN Term
- Imaging lesion localization marker, external, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 892.1640 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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Imaging lesion localization marker, external, single-use
Clear Guide VisiMARKER Non-Sterile by Clear Guide Medical — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Clear Guide Medical
Sources (2)
- FDA UDI d234869b-9308-45d6-8e69-bcbc07f28bc2 34 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 19, 2026