FDA UDI
In Commercial Distribution
🇺🇸 United States
OtoSight Middle Ear Scope
DI: 00850013784004
·
Model: 34R
·
Photonicare, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OtoSight Middle Ear Scope
- Primary DI
- 00850013784004
- Version / Model
- 34R
- Company Name
- Photonicare, Inc.
- Labeler DUNS
- 078873691
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-04-15
- Public Version
- 2
- Public Version Date
- 2022-09-05
- Public Version Status
- Update
- Public Device Record Key
- 6393b361-3a2a-445b-8002-56cf8f8d84b3
Device Description
The OtoSight Middle Ear Scope is intended for use as an imaging tool for real-time visualization of the human tympanic membrane and fluid or air within the middle ear space. In the presence of middle ear fluid, the OtoSight Middle Ear Scope is used to visualize the fluid density. The OtoSight Middle Ear Scope is also used to provide surface images of the ear canal and tympanic membrane. It is indicated for use in children and adults.
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
- No
- PM Exempt
- No
- 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 |
|---|---|---|---|---|
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear | Radiology | 892.1560 | 2 |
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 | 00850013784004 | GS1 | ||||
| Package | 00850013784035 | GS1 | Shipping Box | 1 | In Commercial Distribution | |
| Package | 00850013784141 | GS1 | Box with WA Adapter | 1 | In Commercial Distribution |
Customer Contacts
- Phone
- 18664113277
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191804 | 000 |