FDA.reportPublic FDA data

NeoMagic

Primary DI
B33930530030
Brand
NeoMagic
Company
Neo Medical Inc.
Model
3053-003
Catalog number
3053-003
Device description
3.0Fr x 10cm Tearaway Sheath Dilator Introducer Set
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KZHIntroducer, Syringe Needle

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KZHIntroducer, Syringe NeedleGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K951384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K951384000V-CATH PERCUTANEOUS INTRODUCER KITHdc Corp.1995-06-23KZH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B33930530035PackageHIBCC5In Commercial Distribution
B33930530030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of nonimplantable, invasive devices intended to provide percutaneous vascular access to enable introduction of a catheter (not included) into the vascular system. It includes a non-steerable introducer sheath with an inner obturator/dilator, and typically an additional access device(s) [e.g., guidewire, introducer needle, syringe, additional dilators] which may include a haemostatic valve to control blood loss, usually to enable arterial access. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Gauge3French
Length10Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep Away From Sunlight
Special Storage Condition, Specify00Keep Dry

Contacts#

Phone, Email table
PhoneEmail
888-450-3334support@neomedicalinc.com

Regulatory Flags#

DUNS number
015510540
Device count
1
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
B33919570010NeoMagic1957-0011957-0012026-03-27
B33919580010NeoMagic1958-0011958-0012026-03-27
B33919580020V-Lock1958-0021958-0022026-03-27
B33919580050NeoMagic1958-0051958-0052026-03-27
B33919580060NeoMagic1958-0061958-0062026-03-27
B33919670010NeoMagic1967-0011967-0012026-03-27
B33919770010NeoMagic1977-0011977-0012026-03-27
B33919800010V-Cath1980-0011980-0012026-03-27
B339252526500NeoMagic2525-26502525-26502025-08-18
B339252526505NeoMagic2525-26502525-26502025-08-18
B339194316060NeoMagic1943-16061943-16062016-09-24
B339194316080NeoMagic1943-16081943-16082016-09-24
B339194316250NeoMagic1943-16251943-16252016-09-24
B339194316400NeoMagic1943-16401943-16402016-09-24
B339194416250NeoMagic1944-16251944-16252016-09-24
B339194416300NeoMagic1944-16301944-16302025-01-08
B339194416400NeoMagic1944-16401944-16402016-09-24
B339194416500NeoMagic1944-16501944-16502025-01-08
B339194616060NeoMagic1946-16061946-16062022-03-11
B339194616080NeoMagic1946-16081946-16082022-03-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B33919800010V-CathNeo Medical Inc.KZH2026-03-27
05713495000121SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
05713495000138SKYTROFA Auto-InjectorPhillips-Medisize A/SKZH2025-08-20
57622436104114Glatopaject ®AEROPHARM GmbHKZH2025-08-19
47622436104100Glatopaject ®AEROPHARM GmbHKZH2025-08-19
00860010587317CoolJect Targeted-Mist 1-3cc Nook Syringe Holder AccessoryVapocoolshot, IncKZH2025-08-01
00850037806058Orbit InserterModular Medical, Inc.KZH2025-07-11
00850037806119MODD1 Starter KitModular Medical, Inc.KZH2025-07-11
00850037806126MODD1 Patient Welcome KitModular Medical, Inc.KZH2025-07-11
00370095000002GripMate™SUN PHARMACEUTICAL INDUSTRIES, INC.KZH2025-05-12
05714472000004Needle Guide AssistantUnion Medico ApSKZH2025-05-05
B33935290030NeoMagicNeo Medical Inc.KZH2025-01-22
B33935290035NeoMagicNEO MEDICAL INC.KZH2025-01-22
00860006961510Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00860006961534Coolject 1-3cc Syringe Holder Nozzle AccessoryVapocoolshot, IncKZH2023-01-27
00817708022964AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00817708022988AccuSertEMED TECHNOLOGIES CORPORATIONKZH2022-10-24
00643169705920Sil-serter™MEDTRONIC MINIMED, INC.KZH2022-09-17
00643169768086Minimed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
00763000573690MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2022-07-07
05713495000077Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
05713495000084Skytrofa Auto-InjectorPhillips-Medisize A/SKZH2021-10-22
00763000381080Sil-serter™MEDTRONIC MINIMED, INC.KZH2021-04-22
00763000354817MiniMed™ Quick-serter™MEDTRONIC MINIMED, INC.KZH2020-06-14
05713495000015BETACONNECTPhillips-Medisize A/SKZH2019-10-07
00355513192019Onpro kitAMGEN INC.KZH2019-09-24
10355513192016Onpro kitAMGEN INC.KZH2019-09-24
00301697712901FlexPro® PenMate®NOVO NORDISK INC.KZH2019-08-08
00025294874007Inject-EaseAMBI, INC.KZH2018-12-17
57612799202398Extavia® Auto-Injector IINOVARTIS PHARMACEUTICALS CORPORATIONKZH2018-09-24