FDA.reportPublic FDA data

INTRODUCER

Primary DI
08052286590166
Brand
INTRODUCER
Company
ELESTA SPA
Model
EI AG2 0020 640
Device description
CHIBA introducer needle, 21Gx20.7 cm
Published
2021-06-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
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
08052286590166PackageGS120In Commercial Distribution
08052286590142PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052286590166080522865901668052286590166
08052286590142080522865901428052286590142

GMDN Terms#

Term, Definition table
TermDefinition
Interventional radiology percutaneous-access procedure kitA collection of various sterile radiopaque instruments/devices (e.g., introducer sheath, dilator, needle, angiographic catheter) intended to be used for image-guided, single-puncture, percutaneous access to facilitate an interventional radiology procedure (e.g., bile duct biopsy, percutaneous transhepatic cholangiogram, non-vascular drainage procedures). It does not contain pharmaceuticals. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length207Millimeter
Needle Gauge21Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
895683282
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08052286590500LASER THERMAL THERAPY KIT S EEI KT0 0011 0012026-03-24
08052286590517LASER THERMAL THERAPY KIT L EEI KT0 0011 0022026-03-24
08052286590210Laser Thermal Therapy Kit S EEI KT0 0011 0012023-11-06
08052286590227Laser Thermal Therapy Kit L EEI KT0 0011 0022023-11-06
08052286590012Elesta - IntroducerCH2120. 6EC2019-04-23
08052286590135INTRODUCER EI AG2 0020 6202021-06-19
08052286590142INTRODUCER EI AG2 0020 6402021-06-19
08052286590005Elesta - IntroducerCH2111. 6EC2019-04-23
08052286590159INTRODUCER EI AG2 0020 6202021-06-19
08052286590173Echolaser Smart Interface (ESI)EI KT0 0005 5212021-06-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10198956570955CARDINAL HEALTHCardinal Health 200, LLCGAA2026-09-04
00884450834022MiniStop Plus™Merit Medical Systems, Inc.GAA2026-08-22
00884450681251Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681268Kensington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681275Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681282Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681299Huntington™Merit Medical Systems, Inc.GAA2026-08-21
00884450681374Bedford™Merit Medical Systems, Inc.GAA2026-08-21
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
10192253057461TurkelCardinal Health 200, LLCGAA2026-05-13
08800176593120WHITEROSE MICRO CANNULAUC MedicalGAA2026-04-07
10192253025262MonojectCardinal Health 200, LLCGAA2026-01-16
10192253025125MonojectCardinal Health 200, LLCGAA2026-01-12
08800176593069WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593076WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176593083WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-14
08800176592949WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592956WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592963WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592970WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592987WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592994WHITEROSE MICRO CANNULAUC MedicalGAA2025-10-02
08800176592390WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592406WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592413WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592420WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592444WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08
08800176592451WHITEROSE MICRO CANNULAUC MedicalGAA2025-09-08