FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS Blade-Curved Sinus Blades - Type
DI: 08904428723454
·
Model: EI2217
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS Blade-Curved Sinus Blades - Type
- Primary DI
- 08904428723454
- Version / Model
- EI2217
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-10
- Public Version
- 1
- Public Version Date
- 2024-07-18
- Public Version Status
- New
- Public Device Record Key
- 069c43aa-d235-4f05-8679-c92dd67a2390
Device Description
ENT blades are surgical instruments designed for use in ENT surgery. They are intended for use with a powered instrument system to remove tissue, bone, or other obstructions in the sinuses.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- Yes
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- Yes
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| EQJ | Bur, Ear, Nose And Throat | Ear, Nose, Throat | 874.4140 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47523 | Nasal biopsy curette | A sterile, hand-held, manual instrument designed to remove nasal mucosal cells, intended for laboratory examination and/or testing, usually by gently scraping the inferior surface of the inferior turbinate. The instrument typically has a spoon-like working end and a flexible handle; it is typically made of plastic. It is commonly used to collect samples for testing to determine the respiratory epithelial response to air pollutants and for assessing drug effects [e.g., in cystic fibrosis (CF) patients]. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904428747627 | GS1 | Laminated Box | 1 | In Commercial Distribution | |
| Primary | 08904428723454 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 4.0 | Millimeter | |
| Angle | 15 | degree |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius