FDA.reportPublic FDA data

Always-On Tip Tracked Brush, 15mm L, 1.8mm OD

Primary DI
10815686020535
Brand
Always-On Tip Tracked Brush, 15mm L, 1.8mm OD
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-0352
Catalog number
INS-0352
Published
2016-08-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JAKSystem, X-Ray, Tomography, Computed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAKSystem, X-Ray, Tomography, ComputedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K122106000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122106000SPIN DRIVE ALWAYS-ON TIP TRACKED STEERABLE CATHETER ALWAYS-ON TIP TRACKED SHEATH ALWAYS-ON TIP TRACKED ASPIRATION NEEDLEVeran Medical Technologies, Inc.2012-12-21JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815686020535PackageGS15In Commercial Distribution
00815686020538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081568602053510815686020535
00815686020538008156860205388156860205380815686020538

GMDN Terms#

Term, Definition table
TermDefinition
Flexible endoscopic cytology brush, single-useA device intended to be used in combination with a compatible flexible endoscope to collect cells of the mucosa for pathological diagnosis during endoscopy. It is inserted through the working channel of the endoscope and consists of a flexible insertion portion made of a metal coil or plastic tube, whose distal end is equipped with plastic bristles for harvesting mucosal cells, e.g., during bronchoscopy. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
181714804
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00815686020484SPiN Vision Scope, 6.0mm OD, 3.0mm WCINS-71302023-02-11
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

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