FDA UDI
In Commercial Distribution
🇺🇸 United States
PrecisionPoint
DI: 00860014682926
·
Model: P1003
·
Corbin Clinical Resources, LLC
Product Codes
2
GMDN Terms
1
Identifiers
4
Pkg Device Count
1
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Basic Information
- Brand Name
- PrecisionPoint
- Primary DI
- 00860014682926
- Version / Model
- P1003
- Company Name
- Corbin Clinical Resources, LLC
- Labeler DUNS
- 015831831
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-02-04
- Public Version
- 1
- Public Version Date
- 2026-02-12
- Public Version Status
- New
- Public Device Record Key
- 6e717899-1739-4069-9c27-b8eed79a9244
Device Description
Transperineal Access System
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- Yes
- 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
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| FCG | Biopsy Needle | Gastroenterology, Urology | 876.1075 | 2 |
| ITX | Transducer, Ultrasonic, Diagnostic | Radiology | 892.1570 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45018 | Needle guide, single-use | A rigid, non-powered device designed to direct a sharp needle (not included) into its proper course when performing a clinical and/or surgical procedure; the guide itself is not intended for percutaneous access (not a guide-catheter). Dedicated needle guides are available for different procedures such as urethral injections, image-guided (e.g., ultrasound, MRI) transrectal/transperineal prostate biopsy or ablation, endocavity IVF procedures, percutaneous punctures, nerve blocks, electromagnetic device tracking surgery, and stereotactic breast biopsies. Procedural supportive devices (e.g., ultrasound transducer cover/sheath, drape) may be included with the device. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00860014682926 | GS1 | ||||
| Package | 00860014682919 | GS1 | 5 | In Commercial Distribution | ||
| Package | 00860014682902 | GS1 | 20 | In Commercial Distribution | ||
| Previous | B371P10020 | HIBCC |
Customer Contacts
- Phone
- 603-401-6190
- [email protected]