INT,K2 Microcatheter

GUDID 26950900998823

1.8F-2.5F, 110cm, straight tip,fully hydrophilic coating

Shanghai Kindly Medical Instruments Co., Ltd.

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Primary Device ID26950900998823
NIH Device Record Key8b5fda70-26d4-4b86-9565-34d278457564
Commercial Distribution StatusIn Commercial Distribution
Brand NameINT,K2 Microcatheter
Version Model NumberMCS01-1L
Company DUNS420827639
Company NameShanghai Kindly Medical Instruments Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106950900998829 [Primary]
GS126950900998823 [Package]
Contains: 06950900998829
Package: box [5 Units]
In Commercial Distribution
GS146950900998827 [Package]
Package: carton [25 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQYCatheter, Percutaneous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-09-06
Device Publish Date2023-08-29

On-Brand Devices [INT,K2 Microcatheter]

269509009989391.8F-2.5F, 180cm, curved tip,fully hydrophilic coating
269509009989221.8F-2.5F, 150cm, curved tip,fully hydrophilic coating
269509009989151.8F-2.5F, 130cm, curved tip,fully hydrophilic coating
269509009989081.8F-2.5F, 110cm, curved tip,fully hydrophilic coating
269509009988921.6F-2.3F, 180cm, curved tip,fully hydrophilic coating
269509009988851.6F-2.3F, 150cm,, curved tip,fully hydrophilic coating
269509009988781.6F-2.3F, 130cm, curved tip,fully hydrophilic coating
269509009988611.6F-2.3F, 110cm, curved tip,fully hydrophilic coating
269509009988541.8F-2.5F, 180cm, straight tip,fully hydrophilic coating
269509009988471.8F-2.5F, 150cm, straight tip,fully hydrophilic coating
269509009988301.8F-2.5F, 130cm, straight tip,fully hydrophilic coating
269509009988231.8F-2.5F, 110cm, straight tip,fully hydrophilic coating
269509009988161.6F-2.3F, 180cm, straight tip,fully hydrophilic coating
269509009988091.6F-2.3F, 150cm, straight tip,fully hydrophilic coating
269509009987931.6F-2.3F, 130cm, straight tip,fully hydrophilic coating
269509009987861.6F-2.3F, 110cm, straight tip,fully hydrophilic coating
269509009558021.8F-2.5F, 180cm, curved tip
269509009557961.8F-2.5F, 150cm, curved tip
269509009557891.8F-2.5F, 130cm, curved tip
269509009557721.8F-2.5F, 110cm, curved tip
269509009557651.6F-2.3F, 180cm, curved tip
269509009557581.6F-2.3F, 150cm,, curved tip
269509009557411.6F-2.3F, 130cm, curved tip
269509009557341.6F-2.3F, 110cm, curved tip
269509009557102.8F-3.0F, 150cm, straight tip
269509009557032.8F-3.0F, 130cm, straight tip
269509009556041.8F-2.5F, 180cm, straight tip
269509009555981.8F-2.5F, 150cm, straight tip
269509009555811.8F-2.5F, 110cm, straight tip
269509009555741.6F-2.3F, 180cm, straight tip
269509009555671.6F-2.3F, 110cm, straight tip
269509009343191.6F-2.3F, 150cm, straight tip
269509009342891.8F-2.5F, 130cm, straight tip
269509009296431.6F-2.3F, 130cm, straight tip
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