FDA.reportPublic FDA data

NeoMagic

Primary DI
B33920763000
Brand
NeoMagic
Company
Neo Medical Inc.
Model
2076-300
Catalog number
2076-300
Device description
1.9/2.0 Fr, 27ga, Sharps Safety Needle & Tearaway Sheath Introducer
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYBIntroducer, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYBIntroducer, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K022099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K022099000SAFE-T-PEEL SAFETY NEEDLE/INTRODUCER, MODELS 350-300 S, 360-300'S,380-300'S,390-300'SHdc Corp.2002-09-20FOZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B33920763005PackageHIBCC10In Commercial Distribution
B33920763000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Vascular catheter introduction set, nonimplantableA collection of sterile, 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 Gauge1.9French
Catheter Gauge2French
Needle Gauge27Gauge

Storage And Handling#

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

Sterilization Methods#

Method table
Method

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
10884450834340Prelude EASE™Merit Medical Systems, Inc.DYB2026-10-24
00810024673131FieldFlex SheathCENTERPOINT SYSTEMS LLCDYB2026-10-23
00810024673148FieldFlex SheathCENTERPOINT SYSTEMS LLCDYB2026-10-23
10884450438777Prelude® Short SheathMerit Medical Systems, Inc.DYB2026-10-23
10884450439392Prelude IDeal™Merit Medical Systems, Inc.DYB2026-10-21
00884450840610Prelude Roadster™Merit Medical Systems, Inc.DYB2026-10-20
00821329003455GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00821329003462GORE GUIDRA Steerable SheathGreatbatch LtdDYB2026-10-14
00733132658855GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658862GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658879GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658886GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658893GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658909GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658916GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658923GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658930GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658947GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658954GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658961GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658978GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658985GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132658992GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659005GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659012GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659029GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659036GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659043GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659050GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02
00733132659067GORE® DrySeal Flex Introducer SheathW. L. Gore & Associates, Inc.DYB2024-12-02