FDA.reportPublic FDA data

SPiN Vision Scope, 6.0mm OD, 3.0mm WC

Primary DI
00815686020484
Brand
SPiN Vision Scope, 6.0mm OD, 3.0mm WC
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-7130
Published
2023-02-11
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815686020415PackageGS110Not in Commercial Distribution
00815686020484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815686020415008156860204158156860204150815686020415
00815686020484008156860204848156860204840815686020484

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video bronchoscope, single-useAn endoscope with a flexible inserted portion intended for endoscopic procedures of the airways and tracheobronchial tree (i.e., bronchoscopy). It typically consists of a handle portion and an insertion tube which includes working channels and a distal camera from which anatomical images are transmitted and displayed on a monitor (video bronchoscopy). It is typically intended for flexible optical intubation, airway inspection, and may be used to assist in other diagnostic or therapeutic procedures [e.g., bronchoalveolar lavage (BAL)]. This is a single-use device.

Regulatory Flags#

DUNS number
181714804
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815686020408vPad2 Patient TrackerINS-0050INS-00502016-08-31
00815686020392vPad2 Connector CableINS-0048INS-00482016-08-31
00815686020460SPiN Vision Scope, 4.0mm OD, 2.0mm WCINS-7100INS-71002023-02-11
00815686020446Always-On Tip Tracked Guidewire, 1.0mm, 950mmINS-0305INS-03052016-08-31
00815686020477View Peripheral Catheter, 3.2mm OD, 2.0mm WCINS-0322INS-03222016-08-31
00815686020514Always-On Tip Tracked 20ga Aspiration Needle, 15mm L, 1.8mm ODINS-0342INS-03422016-08-31
00815686020538Always-On Tip Tracked Brush, 15mm L, 1.8mm ODINS-0352INS-03522016-08-31
00815686021160SPiN Access Catheter Adapter, OlympusINS-5901INS-59012020-01-30
00815686021177SPiN Access Catheter, 90 Degree CatheterINS-5911INS-59112021-02-17
00815686021184SPiN Access Catheter Always-On Tip Tracked GuidewireINS-5950INS-59502021-02-17
00815686021191"0.016"" Stylet, 1235mm L"INS-5411INS-54112020-01-30
00815686021207Always-On Tip Tracked Triple Needle Brush, 12mm L, 1.8mm ODINS-5300INS-53002019-10-11
00815686021269SPiN Access Catheter, 180 Degrees For Use With Olympus ScopesINS-5905INS-59052020-01-30
00815686021276SPiN Access Catheter, 90 Degrees For Use With Olympus 190 ScopesINS-5910INS-59102021-02-17
00815686021290SPiN Access Catheter, 180 Degrees For Use With Olympus 190 ScopesINS-5915INS-59152021-02-17
00815686021306SPiN Access Catheter, 90 Degrees For Use With Pentax ScopesINS-5920INS-59202021-02-17
00815686021313SPiN Access Catheter, 180 Degrees For Use With Pentax ScopesINS-5925INS-59252021-02-17
00815686021283SPiN Access Catheter, 180 Degree CatheterINS-5912INS-59122021-02-17
00815686021153SPiN Access Catheter, 90 Degree For Use With Olympus ScopesINS-5900INS-59002020-01-30
00815686021245SPiN Access Catheter Adapter, Olympus 190INS-5902INS-59022020-01-30

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10810068810780Monarch™ Laptop P70 Linux USB Image v2.2.5Auris Health, Inc.EOQ2024-02-16
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