FDA.reportPublic FDA data

Always-On Tip Tracked 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD

Primary DI
00815686020613
Brand
Always-On Tip Tracked 21ga ANSO Cytology Needle, 12mm L, 1.8mm OD
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-0392
Catalog number
INS-0392
Published
2016-08-31
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
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
10815686020610PackageGS15In Commercial Distribution
00815686020613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081568602061010815686020610
00815686020613008156860206138156860206130815686020613

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.

Sterilization Methods#

Method table
Method

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
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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