FDA UDI
In Commercial Distribution
🇺🇸 United States
OSSEOUS
DI: 08904428721955
·
Model: E7191-L
·
EON MEDITECH PRIVATE LIMITED
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- OSSEOUS
- Primary DI
- 08904428721955
- Version / Model
- E7191-L
- Company Name
- EON MEDITECH PRIVATE LIMITED
- Labeler DUNS
- 930270428
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-06-10
- Public Version
- 1
- Public Version Date
- 2024-06-18
- Public Version Status
- New
- Public Device Record Key
- f8fb2999-241d-4a0e-aba4-f91c51c477e6
Device Description
Sinus Packs sponges are designed to be placed inside the sinus cavity for use as temporary tamponade or heamostatis device to control blood oozing or persistent bleeding.
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 |
|---|---|---|---|---|
| EMX | Balloon, Epistaxis | Ear, Nose, Throat | 874.4100 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 47679 | Nasal mucosa dressing, non-antimicrobial | A material (e.g., solution, spray, gel, oil, balm) intended to be applied to nasal mucosa for one or a variety of therapeutic applications such as providing a protective barrier, hydrating the mucosa, washing/removing excessive secretions, loosening nasal encrustations, and/or reducing mucosal irritation/inflammation/oedema from environmental exposures (e.g., pet allergens, pollen), infection, or postsurgical healing, or for snoring control. It is composed of one or a combination of compounds (e.g., acids, provitamins, mannitol); it does not include an antimicrobial agent(s). It is intended for use in the home or a clinical setting. After application, this device cannot be reused. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 08904428745883 | GS1 | Laminated Box | 10 | In Commercial Distribution | |
| Primary | 08904428721955 | GS1 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 3.5 | Centimeter | |
| Height | 1.2 | Centimeter | |
| Width | 0.6 | Centimeter |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 25 Degrees Celsius