Identity
- Trade Name
- Reusable Biopsy Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 6279 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10841912106599 FDA UDI
- 510(k) Number
- K973958 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 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
No
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
High-level Disinfectant FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
Reusable Biopsy Bracket by Protek Medical Products, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasound imaging system tracking positioner, reusable.
- BIOPSY ADAPTOR — Canon Medical Systems Corporation · Class II
- Needle Guide Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- NGB-025 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Verza Guidance System — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- NGB-003 Needle-guided Bracket/DETACH — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
- Verza Guidance System — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
Cleared under the same submission
K973958 also covers:
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Biopsy/Needle Guide/Probe Cover Kit — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director Sterile Disposable Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
- Director XT Multi Gauge Needle Guide — PROTEK MEDICAL PRODUCTS, INC.
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
- Protek Medical Products, Inc.
Sources (1)
- FDA UDI d3c2429f-85f9-403c-8735-8ba21d466d8f 33 fields · synced Jun 8, 2026