FDA.reportPublic FDA data

Always-On Tip Tracked 22ga SPiN Flex Needle, 12mm L, 1.8mm OD

Primary DI
00815686020637
Brand
Always-On Tip Tracked 22ga SPiN Flex Needle, 12mm L, 1.8mm OD
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-5410
Catalog number
INS-5410
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
10815686020634PackageGS15In Commercial Distribution
00815686020637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081568602063410815686020634
00815686020637008156860206378156860206370815686020637

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
00815686020439Always-On Trip Tracked Guidewire, 1.0mm, 735mmINS-0304INS-03042016-08-31
00815686020446Always-On Tip Tracked Guidewire, 1.0mm, 950mmINS-0305INS-03052016-08-31
00815686020064ig4 System V2, 120V, 60HzSYS-2000SYS-20002016-08-31
00815686020071ig4 System V2, 230V, 50HzSYS-2230SYS-22302016-08-31
00815686020088ig4 System, 120V, 60HzSYS-3000SYS-30002016-08-31
00815686020095ig4 System, 230V, 50HzSYS-3230SYS-32302016-08-31
00815686020101SPiN Thoracic Navigation System, 120V, 60HzSYS-4000SYS-40002016-11-16
00815686020118SPiN Thoracic Navigation System, 230V, 50HzSYS-4230SYS-42302016-11-16
0081568602023117ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5022INS-50222016-08-31
0081568602024817ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5023INS-50232016-08-31
0081568602025517ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5024INS-50242016-08-31
0081568602026218ga, 60mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5025INS-50252016-08-31
0081568602027918ga, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5026INS-50262016-08-31
0081568602028618ga, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5027INS-50272016-08-31
0081568602029319 UTW, 155mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5028INS-50282016-08-31
0081568602030919 UTW, 105mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5029INS-50292016-08-31
0081568602031619 UTW, 45mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5030INS-50302016-08-31
0081568602032319 UTW, 100mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5031INS-50312016-08-31
0081568602033019 UTW, 150mm Always-On Tip Tracked Biopsy Needle, Chiba PointINS-5032INS-50322016-08-31

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