FDA.reportPublic FDA data

MicroTaper™ NV Non-Vascular Safety Introducer Set

Primary DI
10860327000285
Brand
MicroTaper™ NV Non-Vascular Safety Introducer Set
Company
SUMMIT ACCESS LLC
Model
SA-15-G100-NT
Published
2022-10-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGZAccessories, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGZAccessories, CatheterGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860327000285PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1086032700028510860327000285

GMDN Terms#

Term, Definition table
TermDefinition
Non-vascular catheter introduction setA collection of sterile, invasive devices intended to enable percutaneous Seldinger-type introduction of a non-vascular catheter (e.g., drainage catheter) into a body cavity or lumen (e.g., biliary tract, ureter); it is not intended for introduction of a peritoneal dialysis catheter. It includes multiple invasive access devices which typically include an introducer needle, introducer sheath with an inner dilator, and guidewire; the catheter is not included. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
021348782
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
10860327000216MicroTaper™ Safety Introducer Set SA-03-G0602016-09-09
10860327000223MicroTaper™ Safety Introducer Set SA-04-G0602016-09-09
10860327000230MicroTaper™ Safety Introducer Set SA-07-G0602016-09-09
10860327000247MicroTaper™ Safety Introducer Set SA-10-G0602016-09-09
10860327000254MicroTaper™ Safety Introducer Set SA-15-G0602016-09-09
10860327000278MicroTaper™ NV Non-Vascular Safety Introducer Set SA-15-G100-NT-MT2022-10-05
10860327000292MicroTaper™ NV Non-Vascular Safety Introducer Set SA-15-G100-NT-ST2022-10-05
20860327000213MicroTaper™ Safety Introducer Set SA-03-G0602016-09-09
20860327000220MicroTaper™ Safety Introducer Set SA-04-G0602016-09-09
20860327000237MicroTaper™ Safety Introducer Set SA-07-G0602016-09-09
20860327000244MicroTaper™ Safety Introducer Set SA-10-G0602016-09-09
20860327000251MicroTaper™ Safety Introducer Set SA-15-G0602016-09-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
H787TDST0AngioDynamicsAngiodynamics, Inc.KGZ2026-06-04
00840329837389BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.KGZ2026-05-04
10198459435201MEDLINE INDUSTRIES, INC.MEDLINE INDUSTRIES, INC.KGZ2025-07-21
10704411017882AMSure® Single Spike Infiltration TubingAMSINO INTERNATIONAL, INC.KGZ2025-06-23
10192253053609DevonCardinal Health 200, LLCKGZ2025-03-25
10192253042023DevonCardinal Health 200, LLCKGZ2025-03-07
10192253042030DevonCardinal Health 200, LLCKGZ2025-03-07
00840306835087Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835094Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835100Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
00840306835131Marina MedicalMARINA MEDICAL INSTRUMENTS, INC.KGZ2025-01-16
30382904275656BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-22
30382904275618BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275625BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275632BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275649BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-20
30382904275601BD Intramedic™ Luer-Stub AdapterBECTON, DICKINSON AND COMPANYKGZ2024-08-16
00815634021761FibrijetMicromedics, Inc.KGZ2024-06-18
00628725047638Safety Drain line adapterCanadian Hospital Specialties LimitedKGZ2024-06-17
10193489068245NAMICMEDLINE INDUSTRIES, INC.KGZ2023-12-21
10193489068108MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068115MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489068122MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140187MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
10193489140194MEDLINEMEDLINE INDUSTRIES, INC.KGZ2023-09-18
M710WW12K0Wire Watch™BIOTEX, INC.KGZ2023-07-31
10850005416002MedDrainARMM INC.KGZ2023-06-08
10850005416019MedDrainARMM INC.KGZ2023-06-08
10850005416033MedDrainARMM INC.KGZ2023-06-08
10850005416071MedDrainARMM INC.KGZ2023-06-08