Identity
- Trade Name
- NGB-003 Needle-guided Bracket/DETACH FDA UDI
- Generic Name
- Ultrasound imaging system tracking positioner, reusable FDA UDI
- Model / Reference
- 115-002026-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904042039 FDA UDI
- FDA Product Code
- OIJ FDA UDI
- GMDN Term
- Ultrasound imaging system tracking positioner, 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Liquid Chemical FDA UDI
MR Unsafe FDA UDI
Category: Ultrasound imaging system tracking positioner, reusable
NGB-003 Needle-guided Bracket/DETACH by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasound imaging system tracking positioner, reusable.
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Cleared under the same submission
K130695 also covers:
- 35C20EA Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-001 Needle-guided Bracket/DETACH — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-001 Needle-guided Bracket/DETACH/VET — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-001 Needle-guided Bracket/VET — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-003 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-003 Needle-guided Bracket/VET — Shenzhen Mindray Bio-Medical Electronics Co.
K183660 also covers:
- DP-20/30 Double probe port module — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-001 Needle-guided Bracket/DETACH — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-003 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-004 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-005 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-007 Needle-guided Bracket/STEEL — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-010 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 5d6978ce-558c-4224-bb12-db4050613393 34 fields · synced Jun 6, 2026