FDA.reportPublic FDA data

Smart Video-Stylet

Primary DI
B881SSCVS1
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
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
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 intubation laryngoscope, video, 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.

Regulatory Flags#

DUNS number
113503058
Device count
15
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B881SSCNDK0Smart VIdeo-Stylet MonitorS-SC-NDKS-SC-NDK2020-11-29
B881SSCVS0Smart Video-StyletS-SC-VSS-SC-VS2020-11-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00190776427610MillenniumAvalign Technologies, Inc.CCW2026-08-26
00198506094071ELMED INCORPORATEDELMED INCORPORATEDCCW2026-08-18
00190776422936MillenniumAvalign Technologies, Inc.CCW2026-08-03
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