NAMIC

Primary DI
H965800450750
Brand
NAMIC
Company
ANGIODYNAMICS, INC.
Model
80045075
Device description
NEEDLE GUIDEWIRE INTRODUCER - OEM
Published
2020-11-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K903606000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K903606000GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCERNorth American Instrument Corp.1990-09-27LIT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
H965800450750PrimaryHIBCC0

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.

Sterilization Methods#

Method table
Method
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
+1(518)795-1676dgreer@angiodynamics.com

Regulatory Flags#

DUNS number
079105071
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
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05051684018527LifeportH787LPS30090LPS30092026-06-23
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05051684018596LifeguardH787LG201500LG-20-1502026-06-23
05051684018602LifeguardH787LG20500LG-20-502026-06-23
05051684018619LifeguardH787LG20750LG-20-752026-06-23
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05051684018640LifeguardH787LG22750LG-22-752026-06-23

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