Single-use Guidewire

GUDID 16971381251637

The guide wire is an introducer, which uses the maneuverability and support characteristics of the guide wire to guide the catheter or other instrument into the cavity.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Gastro-urological guidewire, single-use
Primary Device ID16971381251637
NIH Device Record Key0b897bc6-6326-4fb8-bfb8-af1582839747
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-use Guidewire
Version Model NumberGW-3515
Company DUNS544519831
Company NameSCIVITA MEDICAL TECHNOLOGY CO., LTD.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106971381251630 [Primary]
GS116971381251637 [Package]
Contains: 06971381251630
Package: [5 Units]
In Commercial Distribution
GS126971381251634 [Package]
Package: [180 Units]
In Commercial Distribution

FDA Product Code

OCYEndoscopic Guidewire, Gastroenterology-Urology

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-01
Device Publish Date2023-05-24

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