AccessGUDID - DEVICE: Smart VIdeo-Stylet Monitor (B881SSCNDK0)

GUDID

Device Identifier (DI) Information

Brand Name: Smart VIdeo-Stylet Monitor
Version or Model: S-SC-NDK
Commercial Distribution Status: In Commercial Distribution
Catalog Number: S-SC-NDK
Company Name: SMART VIDEO-STYLET, LLC

Primary DI Number: B881SSCNDK0
Issuing Agency: HIBCC
Commercial Distribution End Date: November 28, 2120
Device Count: 1
Labeler D-U-N-S® Number*: 113503058 *Terms of Use

Device Description: Monitor with connecting and re-charging cables, to be used with video-stylet (comes with IV pole mount)

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
62762	Rigid non-bladed intubation laryngoscope, video	A non-sterile device intended to facilitate the positioning of an endotracheal (ET) tube prior to the delivery of inhalation anaesthesia and/or ventilation. It consists of a thin tubular portion inserted into the ET tube prior to intubation, with an electronic camera at its distal end to transmit anatomical images by a video system to a handle/monitor. It is typically made of memory-alloy material to allow moulding into a shape to facilitate intubation. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CCW	Laryngoscope, Rigid

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f089b93b-3eda-4f7e-a882-7ca17d7340b1
Public Version Date: March 06, 2025
Public Version Number: 2
DI Record Publish Date: November 29, 2020