FDA.reportPublic FDA data

Smart Video-Stylet

Primary DI
B881SSCVS0
Brand
Smart Video-Stylet
Company
SMART VIDEO-STYLET, LLC
Model
S-SC-VS
Catalog number
S-SC-VS
Device description
Smart Video-Stylet Dispenser Box of 15 disposable video-stylets
Published
2020-11-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
CCWLaryngoscope, Rigid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCWLaryngoscope, RigidAnesthesiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B881SSCVS1PrimaryHIBCC0
B881SSCVS0Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Flexible video intubation laryngoscope, single-useA sterile endoscope with a flexible inserted portion intended for the visual examination of the trachea, and to assist the entry and positioning of an airway tube, typically an endotracheal (ET) tube, to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is thin and long to facilitate endoscope entry and the intubation procedure. Anatomical images are transmitted to the user by a video system with an electronic camera at the distal end of the endoscope and the images showing on a monitor. It is typically used during difficult and non-difficult intubation procedures when maintaining an airway open. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113503058
Device count
15
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B881SSCVS1Smart Video-StyletS-SC-VSS-SC-VS2020-11-29
B881SSCNDK0Smart VIdeo-Stylet MonitorS-SC-NDKS-SC-NDK2020-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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08436031035117AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035216AirtraqPRODOL MEDITEC, SACCW2023-08-01
08436031035902AirtraqPRODOL MEDITEC, SACCW2023-08-01
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