FDA UDI
In Commercial Distribution
🇺🇸 United States
Clear Guide VisiMARKER Non-Sterile
DI: B201CGVMNS0
·
Model: CGVMNS
·
CLEAR GUIDE MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- Clear Guide VisiMARKER Non-Sterile
- Primary DI
- B201CGVMNS0
- Version / Model
- CGVMNS
- Catalog Number
- CG-VM-NS
- Company Name
- CLEAR GUIDE MEDICAL, INC.
- Labeler DUNS
- 965399905
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-10-04
- Public Version
- 1
- Public Version Date
- 2022-10-12
- Public Version Status
- New
- Public Device Record Key
- d234869b-9308-45d6-8e69-bcbc07f28bc2
Device 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.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JAC | System, X-Ray, Film Marking, Radiographic | Radiology | 892.1640 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47020 | Imaging lesion localization marker, external, single-use | A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device. | No | Obsolete |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B201CGVMNS0 | HIBCC | ||||
| Package | B201CGVMNS1 | HIBCC | Shelf Box | 25 | In Commercial Distribution | |
| Package | B201CGVMNS3 | HIBCC | Mailer Box | 1 | In Commercial Distribution | |
| Package | B201CGVMNS2 | HIBCC | Shipper Box | 16 | In Commercial Distribution |