Penguin ENT Scope model
Basic Information
- Brand Name
- Penguin ENT Scope model
- Primary DI
- 04711099370047
- Version / Model
- CP1313F6
- Company Name
- OPCOM INC.
- Labeler DUNS
- 657204525
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-20
- Public Version
- 1
- Public Version Date
- 2024-12-30
- Public Version Status
- New
- Public Device Record Key
- ebe95b8f-a192-40ed-a6d5-8520e1e1f83d
Device Description
Penguin Scope is an outstanding medical innovation designed specifically for comprehensive ear examinations. This device is trusted by medical professionals around the world, and its unique design allows for deep penetration into the ear canal and examination of the eardrum, with multiple uses: Penguin Scope can help you detect potential ear infections, earwax buildup, and foreign object invasion. Penguin Scope can regularly assess ear health, which is particularly beneficial for ears that are prone to problems. Penguin Scope cleanses hearing aid equipment to provide peace of mind by maintaining performance and hygiene. Penguin Scope can provide remote medical support, provide initial assessments for professionals, and assist them in making medical treatment decisions.
Device Characteristics
- Single Use
- Yes
- 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
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- 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 |
|---|---|---|---|---|
| 12849 | Otoscope, direct | An electrically-powered, hand-held device designed for examination of the outer ear canal and tympanic membrane (eardrum) by direct viewing through the ear opening. It consists of a main unit (commonly referred to as the head) with a built-in light source intended to illuminate the interior of the ear canal with a detachable cone-shaped tube (speculum) inserted in the ear canal; it may facilitate the application of air pressure for pneumatic otoscopy. A dedicated power supply handpiece and/or an insufflation bulb may be included with the head. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04711099370047 | GS1 |