AccessGUDID - DEVICE: Smart Video-Stylet (B881SSCVS1)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: B881SSCVS1
Issuing Agency: HIBCC
Commercial Distribution End Date: November 28, 2120
Device Count: 15
Labeler D-U-N-S® Number*: 113503058 *Terms of Use

Device Description: Smart Video-Stylet Dispenser Box of 15 disposable video-stylets

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:	Yes
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?
56653	Flexible intubation laryngoscope, video, single-use	A 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.	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: 6435ab5d-153c-45d7-8153-2a9d3ad5e2db
Public Version Date: March 06, 2025
Public Version Number: 2
DI Record Publish Date: November 29, 2020