FDA.reportPublic FDA data

Aspirating Biopsy Needle

Primary DI
B634MBR0000120
Brand
Aspirating Biopsy Needle
Company
Auris Health, Inc.
Model
MBR-000012
Catalog number
MBR-000012
Device description
Aspirating Biopsy Needle
Published
2018-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
EOQBronchoscope (Flexible Or Rigid)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173760000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173760000Monarch Endoscopy Platform (Monarch Platform)Auris Surgical Robotics, Inc.2018-03-22EOQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B634MBR0000121PackageHIBCC3In Commercial Distribution
B634MBR0000120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic biopsy handpiece/needleA sterile flexible device intended to be used to obtain tissue specimens, for histopathological examination, during various endoscopic procedures (e.g., bronchoscopy, gastroscopy). It is typically constructed of a flexible metal coil or plastic tube whose distal end is equipped with a biopsy needle which is operated by a control handle attached at the proximal end of the instrument. It is introduced into the body cavity through an artificial orifice of the body or the working channel of the compatible endoscope. This is a single-use device.

Regulatory Flags#

DUNS number
015823456
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10810068810940MONARCH™ Advanced Imaging Accessory KitMON-000709MON-0007092026-06-02
10810068810841MONARCH™ Navigation SensorsMON-000705MON-0007052026-05-27
10810068810988Monarch Platform, BronchoscopyMON-0000082025-03-03
10810068810858MONARCH™ ControllerMON-000706MON-0007062026-05-27
10810068811046MONARCH™Platform, UrologyMON-000007MON-0000072026-05-05
10810068811053Monarch® Ureteroscopy KitMUR-000011MUR-0000112026-05-05
10810068811077Monarch®Platform Drape KitMUR-000013MUR-0000132026-05-05
10810068811084MONARCH™ Kit Catheter & AccessoriesMUR-000014MUR-0000142026-05-05
10810068811114MONARCH™ Mini-PCNL Suction SetMUR-000017MUR-0000172026-05-05
10810068811060MONARCH™Guided Percutaneous Access KitMUR-000012MUR-0000122026-05-04
10810068811091MONARCH™ Stone Retrieval BasketMUR-000015MUR-0000152026-05-04
10810068811107MONARCH™ Urology Irrigation CartridgeMUR-000016MUR-0000162026-05-04
10810068811121MONARCH™ Ureteroscope ValveMUR-000026MUR-0000262026-05-04
10810068811138MONARCH™ BronchoscopeMBR-000211-BMBR-000211-B2026-04-21
10810068810896Monarch Bronchscope 2.0/Monarch Platform (P2), RefurbishedMON-000006-RFB2025-08-04
10810068811169Monarch Platform, Bronchoscopy 4.1, RefurbishedMON-000008-RFB2025-08-04
B634MON0007090Monarch Advanced Imaging Accessory KitMON-000709MON-0007092021-07-15
10810068810803Monarch Bronchscope 2.0/Monarch Platform (P2)MON-0000062024-05-05
B634MON00000501R0Monarch Endoscopy Platform (P1) System, RefurbishedMON-000005-01R2020-03-25
B634MON000005010 Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-012020-07-13

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