Identity
- Trade Name
- Profile-ESP Radiographic marker FDA UDI
- Generic Name
- Radiographic image marker, manual FDA UDI
- Device Name
- The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required. Length – approximately 36” / Weight – approximately 5 oz. FDA UDI
- Model / Reference
- 3.0 FDA UDI
- Description
- The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required. Length – approximately 36” / Weight – approximately 5 oz. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868579000278 FDA UDI
- FDA Product Code
- JAC FDA UDI
- GMDN Term
- Radiographic image marker, manual 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
No
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Radiographic image marker, manual
Profile-ESP Radiographic marker by Ortho Kinematics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Ortho Kinematics, Inc.
Sources (1)
- FDA UDI ad215eac-d95a-4887-9655-0a95a6767ca0 33 fields · synced May 30, 2026