Inno Hydrowire

GUDID 06971564430395

Suzhou Innomed Medical Device . Co., Ltd.

Peripheral vascular guidewire, manual
Primary Device ID06971564430395
NIH Device Record Keyc181ad9c-4486-4d0b-ab29-d8edbfe57e75
Commercial Distribution StatusIn Commercial Distribution
Brand NameInno Hydrowire
Version Model NumberSW-35-180-A-3-H
Company DUNS560446555
Company NameSuzhou Innomed Medical Device . 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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971564430395 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DQXWire, Guide, Catheter

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-23
Device Publish Date2020-07-15

On-Brand Devices [Inno Hydrowire]

16971564430156SW-35-260-A-3-H
16971564430118SW-35-150-A-3-D
06971564430395SW-35-180-A-3-H

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