Identity
- Trade Name
- EV29L Non-Sterile Reusable PrecisionPoint Adapter FDA UDI
- Generic Name
- Needle guide, reusable FDA UDI
- Device Name
- The EV29L Non-Sterile Reusable PrecisionPoint Adapter is used with the EV29L High Resolution transrectal side fire transducer (UHR-TRUS) for the ExactVu™ high resolution micro-ultrasound system, and the Perineologic PrecisionPoint transperineal needle guide. The adapter shall allow the PrecisionPoint guide to be attached to the EV29L transducer for use with transperineal biopsy. FDA UDI
- Model / Reference
- EV-BIOGR-PP FDA UDI
- Description
- The EV29L Non-Sterile Reusable PrecisionPoint Adapter is used with the EV29L High Resolution transrectal side fire transducer (UHR-TRUS) for the ExactVu™ high resolution micro-ultrasound system, and the Perineologic PrecisionPoint transperineal needle guide. The adapter shall allow the PrecisionPoint guide to be attached to the EV29L transducer for use with transperineal biopsy. FDA UDI
Identifiers
- Catalog Number
- EV-BIOGR-PP FDA UDI
- Primary DI / UDI-DI
- 00628055481225 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Needle guide, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Needle guide, reusable
EV29L Non-Sterile Reusable PrecisionPoint Adapter by Exact Imaging — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Needle guide, reusable.
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Cleared under the same submission
K162972 also covers:
K180636 also covers:
K190995 also covers:
K192303 also covers:
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 II | Pending data |
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Manufacturer
- Manufacturer
- Exact Imaging
Sources (1)
- FDA UDI caa6e306-ebf2-43db-8b87-55cec0d44f99 35 fields · synced May 31, 2026