FDA UDI
In Commercial Distribution
🇺🇸 United States
SOS Shikani Optical Stylet, Adult
DI: B06730000100
·
Model: 30000-10
·
CLARUS MEDICAL, LLC
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SOS Shikani Optical Stylet, Adult
- Primary DI
- B06730000100
- Version / Model
- 30000-10
- Catalog Number
- 30000-10
- Company Name
- CLARUS MEDICAL, LLC
- Labeler DUNS
- 010316284
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-20
- Public Version
- 3
- Public Version Date
- 2025-03-06
- Public Version Status
- Update
- Public Device Record Key
- 202b4bb2-207c-4b80-84ec-32b5d0b4d249
Device Description
SOS Malleable Stylet, (Adult)
Device Characteristics
- Single Use
- No
- 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
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- Yes
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- Yes
- Sterilization Methods
- High-level Disinfectant
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Ear, Nose, Throat | 874.4760 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 36706 | Flexible intubation laryngoscope, fibreoptic | An endoscope with a flexible inserted portion intended for the visual examination of the upper airway and to assist the entry and positioning of a special airway tube [a long thin version of an endotracheal (ET) tube] to secure an open airway in the case of difficult and non-difficult intubation procedures. The inserted portion is very long and thin to facilitate entry and the intubation procedure. Anatomical images are transmitted to the user by the device through a fibreoptic bundle. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B06730000100 | HIBCC |
Customer Contacts
- Phone
- 763-525-8400
- [email protected]