FDA UDI
In Commercial Distribution
🇺🇸 United States
Otoscope
DI: B366OT0300100
·
Model: R00
·
Ecleris
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Otoscope
- Primary DI
- B366OT0300100
- Version / Model
- R00
- Catalog Number
- OT0300100
- Company Name
- Ecleris
- Labeler DUNS
- 043555079
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-18
- Public Version
- 1
- Public Version Date
- 2023-08-28
- Public Version Status
- New
- Public Device Record Key
- 64265793-3815-4b62-84eb-ba1f5d76e79b
Device Description
Otoscope 3mm Ø, 00°, 100mm L
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 |
|---|---|---|---|---|
| ERA | Otoscope | Ear, Nose, Throat | 874.4770 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 44929 | Otoscope, endoscopic | An endoscope with a rigid inserted portion intended to be used in otology mainly for observation, diagnosis, and treatment of the outer and/or middle ear. Anatomical images are transmitted to the user by the device through relayed lens optics or a fibreoptic bundle typically with images displayed on a monitor. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B366OT0300100 | HIBCC |
Customer Contacts
- Phone
- 786-483-7490
- [email protected]
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -10 – 40 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 19 – 90 Percent (%) Relative Humidity