FDA.reportPublic FDA data

17ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point

Primary DI
00815686020217
Brand
17ga, 155mm Always-On Tip Tracked Biopsy Needle, Chiba Point
Company
VERAN MEDICAL TECHNOLOGIES INC.
Model
INS-5016
Catalog number
INS-5016
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
K093146000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093146000IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200Veran Medical Technologies, Inc.2009-11-30JAK

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10815686020214PackageGS15In Commercial Distribution
00815686020217PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081568602021410815686020214
00815686020217008156860202178156860202170815686020217

GMDN Terms#

Term, Definition table
TermDefinition
Soft-tissue biopsy needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to percutaneously obtain a specimen of soft tissue, typically for histopathological examination. The device is usually attached to a syringe for the aspiration of the specimen; it is available in a variety of lengths, diameters (bores), and tip configurations (e.g., straight or curved). 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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