FDA UDI
In Commercial Distribution
🇺🇸 United States
EV29L Non-Sterile Reusable PrecisionPoint Adapter
DI: 00628055481225
·
Model: EV-BIOGR-PP
·
Exact Imaging Inc
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- EV29L Non-Sterile Reusable PrecisionPoint Adapter
- Primary DI
- 00628055481225
- Version / Model
- EV-BIOGR-PP
- Catalog Number
- EV-BIOGR-PP
- Company Name
- Exact Imaging Inc
- Labeler DUNS
- 203044268
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-05-05
- Public Version
- 1
- Public Version Date
- 2025-05-13
- Public Version Status
- New
- Public Device Record Key
- caa6e306-ebf2-43db-8b87-55cec0d44f99
Device 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.
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Moist Heat or Steam Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OIJ | Biopsy Needle Guide Kit | Radiology | 892.1560 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 60734 | Needle guide, reusable | A non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure. Dedicated needle guides are available for many different procedures such as plastic guides for urethral injections, stainless steel guides for transrectal prostate biopsy, guides for ultrasound-guided percutaneous punctures and nerve blocks, guides for electromagnetic device tracking systems, and guides for stereotactic breast biopsies. This is a reusable device intended to be sterilized/disinfected prior to use. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00628055481225 | GS1 |