OtoSight Middle Ear Scope with Battery
- Primary DI
- 00850013784134
- Brand
- OtoSight Middle Ear Scope with Battery
- Company
- Photonicare, Inc.
- Model
- 34R
- 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.
- Published
- 2023-08-20
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| QJG | Device System, Imaging, Tympanic Membrane And Middle Ear | Radiology | 2 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00850013784134 | Package | GS1 | 1 | In Commercial Distribution |
| 00850013784158 | Package | GS1 | 1 | In Commercial Distribution |
| 00850013784127 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|
| 00850013784134 | 00850013784134 | 850013784134 | 0850013784134 |
| 00850013784158 | 00850013784158 | 850013784158 | 0850013784158 |
| 00850013784127 | 00850013784127 | 850013784127 | 0850013784127 |
GMDN Terms
| Term | Definition |
|---|
| 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. |
Regulatory Flags
- DUNS number
- 078873691
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- Manufacturing date on label
- true
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00850013784004 | OtoSight Middle Ear Scope | 34R | | 2022-04-15 |
| 00850013784110 | OtoSight Speculum Tip Combination Package | Combo | | 2022-04-15 |
| 00850013784097 | Large OtoSight Speculum Tip QTY 20 | Large | | 2022-04-15 |
| 10850013784087 | Standard Otosight Speculum Tip QTY 20 | Standard | | 2022-04-15 |
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00850013784004 | OtoSight Middle Ear Scope | Photonicare, Inc. | QJG | 2022-04-15 |
| 00850013784110 | OtoSight Speculum Tip Combination Package | Photonicare, Inc. | QJG | 2022-04-15 |
| 00850013784097 | Large OtoSight Speculum Tip QTY 20 | Photonicare, Inc. | QJG | 2022-04-15 |
| 10850013784087 | Standard Otosight Speculum Tip QTY 20 | Photonicare, Inc. | QJG | 2022-04-15 |
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