Single-use Broncho Videoscope

GUDID 16971381254706

The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope and an Endoscopic Image Processor including the foot switch. The proposed device has been designed to be used for endoscopic diagnosis and therapies within the respiratory system such as trachea, bronchi and lungs.

SCIVITA MEDICAL TECHNOLOGY CO., LTD.

Flexible video bronchoscope, single-use
Primary Device ID16971381254706
NIH Device Record Keybb33257e-7dfc-4f6d-9ded-2edfa822fa83
Commercial Distribution StatusIn Commercial Distribution
Brand NameSingle-use Broncho Videoscope
Version Model NumberSBV-1B-P
Company DUNS544519831
Company NameSCIVITA MEDICAL TECHNOLOGY 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
GS106971381254709 [Primary]
GS116971381254706 [Package]
Contains: 06971381254709
Package: [1 Units]
In Commercial Distribution
GS126971381254703 [Package]
Package: [22 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EOQBronchoscope (Flexible Or Rigid)

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-17
Device Publish Date2023-11-09

On-Brand Devices [Single-use Broncho Videoscope]

16971381254706The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope
16971381254690The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope
16971381254683The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope
16971381254676The proposed device, Broncho Videoscope System is consisting of a Single-use Broncho Videoscope

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