FDA.report

NAMIC

Primary DI
20193489069348
Brand
NAMIC
Company
MEDLINE INDUSTRIES, INC.
Model
91400400
Catalog number
91400400
Device description
GUIDEWIRE INTRODUCER PG
Published
2021-07-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
LITCatheter, angioplasty, peripheral, transluminal

Product Code Classifications

CodeDeviceSpecialtyClass
LITCatheter, Angioplasty, Peripheral, TransluminalCardiovascular2

Premarket Submissions

SubmissionSupplement
K903606000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K903606000GUIDEWIRE TORQUE DEVICE AND GUIDEWIRE INTRODUCERNorth American Instrument Corp.1990-09-27LIT

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20193489069348PackageGS110In Commercial Distribution
10193489069341PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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40888277358462MEDLINEMPHPN318MPHPN3182026-03-19
20197344009807HUDSON RCIHUD2417HUD24172026-03-19
20080196286789MEDLINEMDT2168282MDT21682822016-10-14
20080196765574MEDLINE INDUSTRIES, INC.NONLV200NONLV2002025-05-28
10197344010264HUDSON RCIHUD1846HUD18462026-03-19
20884389108199MEDLINE INDUSTRIES, INC.NONLV200XXXLNONLV200XXXL2024-03-05
20884389108229MEDLINENONLV200XXLNONLV200XXL2025-05-27
20884389155360MEDLINENONLV240NONLV2402025-05-27
20884389155377MEDLINENONLV240XLNONLV240XL2025-05-27
20888277336893MEDLINENON50240NON502402025-05-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06091403562626Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562633Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562640Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562657Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562664Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562671Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562688Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562695Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562701Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562718Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562725Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562732Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562749Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562756Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562763Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562770Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562787Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562794Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562800Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562817Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562824Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562831Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562848Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562855Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562862Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562879Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562886Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562893Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562909Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29
06091403562916Amethyst HP PTA OTW 0.035" catheterNATEC MEDICAL LTDLIT2026-01-29