Identity
- Trade Name
- Prophecy FDA UDI
- Generic Name
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
- Device Name
- PROPHECY® ALIGNMENT GUIDES FDA UDI
- Model / Reference
- PNV09300 FDA UDI
- Description
- PROPHECY® ALIGNMENT GUIDES FDA UDI
Identifiers
- Catalog Number
- PNV09300 FDA UDI
- Primary DI / UDI-DI
- 00192629346208 FDA UDI
- FDA Product Code
- MBH FDA UDIJWH FDA UDI
- GMDN Term
- Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3565 FDA UDI888.3560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
Yes
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
Yes
Category: Custom-made orthopaedic/craniofacial surgical guide
Unlock the precision and accuracy of Prophecy alignment guides with this custom-made orthopedic surgical instrument. Designed to assist in intraoperative orientation, outlining desired cut-lines, and guiding surgical instruments, Prophecy aligns perfectly with your patient-specific contours. Our single-use device is manufactured by 3D printing and CAD/CAM techniques, ensuring precise match to the target anatomical site. With a proven track record of accuracy and reliability, Prophecy align guides are the go-to choice for orthopedic and craniomaxillofacial procedures.
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- Prophecy — MicroPort Orthopedics Inc. · Class II
- Prophecy — MicroPort Orthopedics Inc. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- MicroPort Orthopedics Inc.
Sources (1)
- FDA UDI 6ac190e7-425c-4fcf-b827-4aa50db4f1bc 36 fields · synced Oct 6, 2026