FDA.reportPublic FDA data

iNod™ Ultrasound Guided Biopsy Ne

Primary DI
00191506020729
Brand
iNod™ Ultrasound Guided Biopsy Ne
Company
BOSTON SCIENTIFIC CORPORATION
Model
M00502060
Catalog number
M00502060
Device description
Biopsy Needle
Published
2023-03-21
Public version status
Update
Distribution status
Not 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
EOQBronchoscope (flexible or rigid)
ITXTransducer, ultrasonic, diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EOQBronchoscope (Flexible Or Rigid)Ear, Nose, Throat2
ITXTransducer, Ultrasonic, DiagnosticRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00191506020729PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00191506020729001915060207291915060207290191506020729

GMDN Terms#

Term, Definition table
TermDefinition
Body aspiration needle, single-useA sterile, sharp bevel-edged, hollow tubular metal instrument designed to remove fluid from a body cavity or to obtain a biopsy specimen from a patient through aspiration; it is not dedicated to a particular part of the anatomy. The device is typically longer than a hypodermic needle and usually has a wider hub. It is not intended for administration of pharmaceuticals. This is a single-use device.

Regulatory Flags#

DUNS number
021717889
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
false
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
08714729749172RX Cholangiogram KitM005714802016-09-24
00191506020910iNod™ Ultrasound Guidance ConsoM00503210M005032102023-03-21
00191506020927iNod™ Ultrasound Guidance ConsoM0050321R0M0050321R02023-03-21
00191506020934iNod™M00503300M005033002023-03-21
00191506020941iNod™M0050330R0M0050330R02023-03-21
00191506021924iNod™M00503200M005032002023-03-21
00191506021931iNod™M0050320R0M0050320R02023-03-21
08714729860853Expel™ Drainage Catheter with Twist-Loc™ HubH74939341082502016-08-17
08714729860860Expel™ Drainage Catheter with Twist-Loc™ HubH74939341102502016-08-17
08714729860877Expel™ Drainage Catheter with Twist-Loc™ HubH74939341122502016-08-17
08714729860884Expel™ Drainage Catheter with Twist-Loc™ HubH74939341142502016-08-17
08714729860891Expel™ Drainage Catheter with Twist-Loc™ HubH749393410825K12016-08-17
08714729860907Expel™ Drainage Catheter with Twist-Loc™ HubH749393411025K12016-08-17
08714729860914Expel™ Drainage Catheter with Twist-Loc™ HubH749393411225K12016-08-17
00802526623400NA694669462024-08-29
00802526604430INGEVITY™+78402020-02-06
00802526604522INGEVITY™+78422020-02-06
00802526604577INGEVITY™+78412020-02-06
00802526480546NA662866282014-09-24
00802526488900NA60402014-09-24

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