FDA UDI
In Commercial Distribution
🇺🇸 United States
Nasal Sponges Sterile
DI: 00840117340206
·
Model: 3168
·
Dynarex Corporation
Product Codes
1
GMDN Terms
1
Identifiers
3
Pkg Device Count
1
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Basic Information
- Brand Name
- Nasal Sponges Sterile
- Primary DI
- 00840117340206
- Version / Model
- 3168
- Company Name
- Dynarex Corporation
- Labeler DUNS
- 008124539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2024-12-16
- Public Version
- 1
- Public Version Date
- 2024-12-24
- Public Version Status
- New
- Public Device Record Key
- 262cb02e-92ff-4b23-a02e-42f44f818ba7
Device Description
Sterile-R
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 18716 | Nasal haemostatic catheter | A tubular device intended to be inserted into the nose to control nose bleeding (epistaxis) by direct pressure. It is typically a single-lumen tube with a sponge attached near its distal tip, and may include an integral airway that allows the patient to breathe through the nose while the catheter is in place. Some designs consist of a double-lumen with a balloon attached to each distal end to be used simultaneously in both nasal cavities and can also be used to stabilize zygomatic arch fractures. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00840117340206 | GS1 | ||||
| Package | 00840117340268 | GS1 | Box | 3 | In Commercial Distribution | |
| Package | 00840117324763 | GS1 | Case | 100 | In Commercial Distribution |