Identity
- Trade Name
- OSSEOUS FDA UDI
- Generic Name
- Nasal biopsy curette FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- EI2210 FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08904461000376 FDA UDI
- FDA Product Code
- EQJ FDA UDI
- GMDN Term
- Nasal biopsy curette FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.4140 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Angle — 0 degree FDA UDIOuter Diameter — 2.9 Millimeter FDA UDI
Category: Nasal biopsy curette
Osseous by Eon Meditech Private Limited — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Nasal biopsy curette.
- OSSEOUS Blade-Curved Sinus Blades - M Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blade-Curved Sinus Blades - N Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blade - Inferior turbinate - M Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blade-Curved Sinus Blades - M Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blade-Tonsillectomy and adenoidectomy Blades - N Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blade - Inferior turbinate - N Type — EON MEDITECH PRIVATE LIMITED · Class I
- OSSEOUS Blades-Straight Sinus Blades - N Type — EON MEDITECH PRIVATE LIMITED · Class I
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Eon Meditech Private Limited
Sources (1)
- FDA UDI ddd60134-340a-4046-97ef-c85e107751c8 35 fields · synced May 31, 2026