FDA UDI
In Commercial Distribution
🇺🇸 United States
Smart Video-Stylet
DI: B881SSCVS1
·
Model: S-SC-VS
·
SMART VIDEO-STYLET, LLC
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
15
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Basic Information
- Brand Name
- Smart Video-Stylet
- Primary DI
- B881SSCVS1
- Version / Model
- S-SC-VS
- Catalog Number
- S-SC-VS
- Company Name
- SMART VIDEO-STYLET, LLC
- Labeler DUNS
- 113503058
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 15
- Record Status
- Published
- Publish Date
- 2020-11-29
- Public Version
- 2
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- 6435ab5d-153c-45d7-8153-2a9d3ad5e2db
- Distribution End Date
- 2120-11-28
Device Description
Smart Video-Stylet Dispenser Box of 15 disposable video-stylets
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- MR Unsafe
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| CCW | Laryngoscope, Rigid | Anesthesiology | 868.5540 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Unit of Use | B881SSCVS0 | HIBCC | ||||
| Primary | B881SSCVS1 | HIBCC |