FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS
DI: 08906039310610
·
Model: E7161
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS
- Primary DI
- 08906039310610
- Version / Model
- E7161
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-11
- Public Version
- 1
- Public Version Date
- 2024-06-19
- Public Version Status
- New
- Public Device Record Key
- 10bab532-2aaa-4308-ac80-dec456609868
Device Description
Ear PVA Dressings sponges are designed to be placed inside ear canal for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding and aid the treatment of otitis external.
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| KCN | Ear Wick | Ear, Nose, Throat | 874.5220 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 33468 | Ear wick, non-biodegradable | A non-biodegradable packing material [e.g., loosely twisted unspun cotton, gauze, or polyvinyl alcohol (PVA)] intended to be used in the ear of a patient after internal ear surgery, and/or to administer medicinal substances to the ear to treat ear disorders. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08906039313390 | GS1 | Laminated Box | 20 | In Commercial Distribution | |
| Primary | 08906039310610 | GS1 | ||||
| Package | 08904428717927 | GS1 | Laminated Box | 10 | In Commercial Distribution |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Outer Diameter | 9 | Millimeter | |
| Length | 15 | Millimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius