FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS Rosen Inserter
DI: 08904461000321
·
Model: EI0959
·
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 Rosen Inserter
- Primary DI
- 08904461000321
- Version / Model
- EI0959
- 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
- b8c1458e-23ee-4f37-9a49-6044e6a058d9
Device Description
"Rosen Inserter are used to hook out wax or foreign bodies from the ear canal. "
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 |
|---|---|---|---|---|
| 65240 | Tympanostomy tube inserter, single-use | A hand-held device intended to direct the insertion and placement of a tympanostomy tube (otherwise known as a myringotomy tube, grommet or an aural vent tube) through the external ear canal during ear/nose/throat (ENT) surgery. A tympanostomy tube is a device used to provide drainage from the middle ear through the tympanic membrane; the inserter is removed once the tube has been inserted. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904461007177 | GS1 | Laminated Box | 100 | In Commercial Distribution | |
| Primary | 08904461000321 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 145 | Millimeter | |
| Outer Diameter | 0.50 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius