FDA.reportPublic FDA data

Coaxial Interventional Needle

Primary DI
04262410680340
Brand
Coaxial Interventional Needle
Company
ITP Innovative Tomography Products GmbH
Model
KIM15/09T
Device description
This needle is intended for puncture and injection.
Published
2025-03-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GAANeedle, Aspiration And Injection, DisposableGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04262410680357PackageGS120In Commercial Distribution
04262410680340PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04262410680357042624106803574262410680357
04262410680340042624106803404262410680340

GMDN Terms#

Term, Definition table
TermDefinition
Hypodermic needle, single-useA non-dedicated, sharp bevel-edged, hollow tubular device intended to be inserted beneath the skin of a patient while connected to a noninvasive device (e.g., syringe, secondary medication set) to administer and/or withdraw (aspirate) fluids/drugs; it may also be used for fluid/drug preparation. Some types are designed with a shielding mechanism (e.g., safety cap) for protection from sharp injuries. It is not specifically designed for blood collection or artery puncture, and does not have wings for fixation/placement (i.e., not a blood collection, intra-arterial, or venous butterfly needle). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length94Millimeter
Needle Gauge15Gauge

Regulatory Flags#

DUNS number
341493551
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04262410680821Semi-automatic Biopsy Needle - BIM16/10iBIM16/10i2025-09-12
04262410680852Semi-automatic Biopsy Needle - BIM18/10iBIM18/10i2025-09-12
04262410687073Semi-automatic Biopsy Needle - BIM16/20iBIM16/20i2025-09-12
04262410687110Semi-automatic Biopsy Needle - BIM16/15iBIM16/15i2025-09-12
04262410680838Semi-automatic Biopsy Needle - BIM16/10iBIM16/10i2025-09-12
04262410680845Semi-automatic Biopsy Needle - BIM18/10iBIM18/10i2025-09-12
04262410687080Semi-automatic Biopsy Needle - BIM16/20iBIM16/20i2025-09-12
04262410687127Semi-automatic Biopsy Needle - BIM16/15iBIM16/15i2025-09-12
04262410687059Semi-automatic Biopsy Needle - BIM18/15iBIM18/15i2025-07-09
04262410687066Semi-automatic Biopsy Needle - BIM18/15iBIM18/15i2025-07-09
04262410687011Semi-automatic Biopsy Needle - BIM18/20iBIM18/20i2025-04-29
04262410687028Semi-automatic Biopsy Needle - BIM18/20iBIM18/20i2025-04-29
04262410686083Automatic Biopsy Needle - BAM 16/17BAM16/172025-04-23
04262410686106Automatic Biopsy Needle - BAM 16/15BAM16/152025-04-23
04262410686090Automatic Biopsy Needle - BAM 16/17BAM16/172025-04-23
04262410686113Automatic Biopsy Needle - BAM 16/15BAM16/152025-04-23
04262410680166Coaxial Interventional NeedleKIM18/102025-04-08
04262410680173Coaxial Interventional NeedleKIM18/102025-04-08
04262410680357Coaxial Interventional NeedleKIM15/09T2025-03-13
04262410680029Coaxial Interventional NeedleKIM22/052025-01-09

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800176592505WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
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08800176592536WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592543WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
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08800176592598WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08