DEVICE: Smart Video-Stylet (B881SSCVS1)
Device Identifier (DI) Information
Smart Video-Stylet
S-SC-VS
In Commercial Distribution
S-SC-VS
SMART VIDEO-STYLET, LLC
S-SC-VS
In Commercial Distribution
S-SC-VS
SMART VIDEO-STYLET, LLC
Smart Video-Stylet Dispenser Box of 15 disposable video-stylets
Device Characteristics
MR Unsafe | |
No | |
No | |
Yes | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
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 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
6435ab5d-153c-45d7-8153-2a9d3ad5e2db
March 06, 2025
2
November 29, 2020
March 06, 2025
2
November 29, 2020
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
B881SSCVS0
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
No Customer Contact currently defined