Identity
- Trade Name
- Aspirating Biopsy Needle FDA UDI
- Generic Name
- Flexible endoscopic biopsy handpiece/needle FDA UDI
- Device Name
- Aspirating Biopsy Needle FDA UDI
- Model / Reference
- MBR-000012 FDA UDI
- Description
- Aspirating Biopsy Needle FDA UDI
Identifiers
- Catalog Number
- MBR-000012 FDA UDI
- Primary DI / UDI-DI
- B634MBR0000120 FDA UDI
- 510(k) Number
- K173760 FDA UDI
- FDA Product Code
- EOQ FDA UDI
- GMDN Term
- Flexible endoscopic biopsy handpiece/needle FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.4680 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Flexible endoscopic biopsy handpiece/needle
Aspirating Biopsy Needle by Auris Health, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Flexible endoscopic biopsy handpiece/needle.
- ClearTip — Finemedix Co., Ltd. · Class II
- ClearTip — Finemedix Co., Ltd. · Class II
- ClearTip — Finemedix Co., Ltd. · Class II
- ViziShot FLEX — Gyrus Acmi, Inc. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
- ELMED — ELMED INCORPORATED · Class I
- ClearTip — Finemedix Co., Ltd. · Class II
- Disposable Endoscope Injection Needle — Yangzhou Fartley Medical Instrument Technology Co., Ltd. · Class II
Cleared under the same submission
K173760 also covers:
- Biopsy Forceps - Smooth Cup — Auris Health, Inc
- Bronchoscope Fluidics Tubing — Auris Health, Inc
- Bronchoscope Patient Introducer Kit — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Sheath Valve — Auris Health, Inc
- Bronchoscope Valve — Auris Health, Inc
- Cytology Brush — Auris Health, Inc
- Monarch Endoscopy Platform (P1) Tower Upgrade — Auris Health, Inc
- Monarch Software Laptop v2.1.6 — Auris Health, Inc
- Monarch Software Laptop v2.2.1 — Auris Health, Inc
- Monarch Software Tower v2.1.6 — Auris Health, Inc
- Monarch™ Bronchoscope System — Auris Health, 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Auris Health, Inc.
Sources (1)
- FDA UDI c80e8278-ae09-407e-926c-b50f2ad3f281 35 fields · synced Jun 8, 2026