Identity
- Trade Name
- NGB-027 Needle-guided Bracket FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 120-003671-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904097688 FDA UDI
- FDA Product Code
- ITX FDA UDIOIJ FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
NGB-027 Needle-guided Bracket by Shenzhen Mindray Bio-Medical Electronics Co. — 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
- Multi Angle Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Needle Guide Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Biopsy Starter Kit — PROTEK MEDICAL PRODUCTS, INC.
- Biopsy Starter Kit — CIVCO MEDICAL INSTRUMENTS CO., INC. · Class II
- Reusable Biopsy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
- Reusable Multi Angle Biospy Bracket — PROTEK MEDICAL PRODUCTS, INC. · Class II
Cleared under the same submission
K163690 also covers:
- 4D and TEE Driver Module Board — Shenzhen Mindray Bio-Medical Electronics Co.
- D7-2E Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module Kit(2145/AHA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Lithium-ion Battery Pack(2145/FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- S-VIDEO -VIDEO Wire — Shenzhen Mindray Bio-Medical Electronics Co.
- V11-3EUltrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
K192152 also covers:
- DC-86 Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-86S Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-89 Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-TQ Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-TV Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-024 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 4850781f-ea48-4736-982b-b29044100aad 33 fields · synced May 30, 2026