FDA.reportPublic FDA data

Elesta - Introducer

Primary DI
08052286590005
Brand
Elesta - Introducer
Company
ELESTA SPA
Model
CH2111. 6EC
Device description
CHIBA Introducer needle, 21Gx11.6 cm
Published
2019-04-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
GAANeedle, Aspiration And Injection, Disposable
GDFGuide, Needle, Surgical

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08052286590029PackageGS120In Commercial Distribution
08052286590005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08052286590029080522865900298052286590029
08052286590005080522865900058052286590005

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
Length116Millimeter
Needle Gauge21Gauge

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
895683282
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

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
08052286590159INTRODUCER EI AG2 0020 6202021-06-19
08052286590166INTRODUCER EI AG2 0020 6402021-06-19
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
00850084501012Xpansion® Micro-Autografting KitNEW HORIZON HEALTHCARE MANAGEMENT LLCGDF2026-07-28
10198956515482CARDINAL HEALTHCardinal Health 200, LLCGAA2026-07-27
06976712970334Hemo NeedleMicro-Energy Medical Technology Co., LtdGDF2026-07-13
05060212050038Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-11
04048223069738TunnEler 235Pajunk GmbH MedizintechnologieGDF2026-06-10
05060212050021Aspirating Needle 335 x 3.5mm (18g) with LuerDTR MEDICAL LIMITEDGAA2026-06-10
ESAM14762481STOMA®Storz am Mark GmbHGDF2025-04-30
08056138586338MarkXM.D.L. S.R.L.GDF2025-02-28
08057276004715MarkXM.D.L. S.R.L.GDF2025-02-28
ESAM14755481STOMA®Storz am Mark GmbHGDF2023-11-20
ESAM14760481STOMA®Storz am Mark GmbHGDF2023-06-05
ESAM14761481STOMA®Storz am Mark GmbHGDF2023-06-05
M68920510060Sentinel Chest Trauma KitSafeguard US Operating, LLCGAA2022-11-28
ESAM14750481STOMA®Storz am Mark GmbHGDF2022-11-07
ESAM14751481STOMA®Storz am Mark GmbHGDF2022-11-07
M68920510050Sentinel Chest Trauma KitSafeguard US Operating, LLCGAA2022-08-18
00886333003594Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003600Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003617Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003624Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333003631Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05
00886333007554Breast Localization NeedlesARGON MEDICAL DEVICES, INC.GAA2022-07-05