FDA.reportPublic FDA data

Coaxial Interventional Needle

Primary DI
04262410680357
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
OTC
false
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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
341493551
Device count
1
DM exempt
false
Premarket exempt
true
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
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
04262410680340Coaxial 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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10198956491298CARDINAL HEALTHCardinal Health 200, LLCGAA2026-10-12
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