FDA UDI
In Commercial Distribution
🇺🇸 United States
LARYNGOSTROBOSCOPE
DI: B366SL103G21
·
Model: RX1
·
Ecleris
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- LARYNGOSTROBOSCOPE
- Primary DI
- B366SL103G21
- Version / Model
- RX1
- Catalog Number
- SL103G21
- Company Name
- Ecleris
- Labeler DUNS
- 043555079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-30
- Public Version
- 1
- Public Version Date
- 2022-07-08
- Public Version Status
- New
- Public Device Record Key
- 3b8538b6-d718-4f36-98d6-7706a9d6f3c3
Device Description
LARYNGOSTROBOSCOPE
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- PM Exempt
- Yes
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EQL | Laryngostroboscope | Ear, Nose, Throat | 874.4750 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 12294 | Laryngostroboscope | A device that is intended to allow the observation of glottic action during phonation (speech) in the examination of voice disorders. The device operates by focusing a stroboscopic light through a lens for direct or mirror reflected viewing of glottic action. It can contain a microphone that captures the acoustic signals from the glottic area and may or may not contact the patient. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B366SL103G21 | HIBCC |
Customer Contacts
- Phone
- 786-483-7490
- [email protected]
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 40 Degrees Celsius
- Type
- Handling Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Temperature
- Temperature Range
- -30 – 50 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 95 Percent (%) Relative Humidity
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 50 – 106 KiloPascal