FDA UDI
In Commercial Distribution
🇺🇸 United States
Post-Stop™ Epistaxis Catheter
DI: EBES60403P0
·
Model: 60-403P
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Post-Stop™ Epistaxis Catheter
- Primary DI
- EBES60403P0
- Version / Model
- 60-403P
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2017-03-28
- Public Version
- 6
- Public Version Date
- 2022-08-30
- Public Version Status
- Update
- Public Device Record Key
- 72f19d99-c656-40de-8c55-a4943c83a049
Device Description
Type: Posterior
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
- MR Safe
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| 12699 | Nasal haemostatic balloon | A device consisting of a hollow rubber or rubber-like structure, expandable with either liquid or air, intended to be used to control nose bleeding (epistaxis) of the anterior or posterior nasal cavity. It is applied during an ear/nose/throat (ENT) intervention and can also be used to treat glue ear in children, and/or to support the structure and patency of the nasal canal. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | EBES60403P0 | HIBCC |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K972078 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry