FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS Myringotomy knife
DI: 08906039319668
·
Model: EI0966
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
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Basic Information
- Brand Name
- OSSEOUS Myringotomy knife
- Primary DI
- 08906039319668
- Version / Model
- EI0966
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-07-04
- Public Version
- 1
- Public Version Date
- 2024-07-12
- Public Version Status
- New
- Public Device Record Key
- d3c74f86-54ec-47cc-a062-c6a4dccf38be
Device Description
Myringotomy Knife is used to make an incision in the tympanic membrane (ear drum) into which a “Grommet” can be placed. The handle design aids orientation for accuracy and confidence when making incisions. The consistently sharp, angled blade facilitates a clean cut.
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 |
|---|---|---|---|---|
| JYG | Curette, Ear | Ear, Nose, Throat | 874.4420 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38103 | Nasal knife | A hand-held manual surgical instrument designed to cut and dissect internal nasal tissue, including the nasal septum, during ear/nose/throat (ENT) surgery. It is typically a one-piece instrument made of high-grade stainless steel with a long, slender shaft with a handle at the proximal end and a sharp, single-edged, cutting blade at the distal end. The blade is normally small and typically of various forms (e.g., sharply-pointed, double-edged, with swivel devices) according to the procedure to be performed (e.g., submucous dissection, septal surgery). This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904461009294 | GS1 | Laminated Box | 10 | In Commercial Distribution | |
| Primary | 08906039319668 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 5.38 | Millimeter | |
| Length | 172 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius