FDA UDI
In Commercial Distribution
🇺🇸 United States
Salman FES Stent
DI: 14063107102155
·
Model: SS2000
·
Boston Medical Products, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1
Basic Information
- Brand Name
- Salman FES Stent
- Primary DI
- 14063107102155
- Version / Model
- SS2000
- Catalog Number
- SS2000
- Company Name
- Boston Medical Products, Inc.
- Labeler DUNS
- 131855157
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-08-31
- Public Version
- 1
- Public Version Date
- 2022-09-08
- Public Version Status
- New
- Public Device Record Key
- 624e17e0-71ab-4e7c-8691-c64407eca709
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 |
|---|---|---|---|---|
| KAM | Cannula, Sinus | General, Plastic Surgery | 878.4800 | 1 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48121 | Paranasal sinus spacer | A sterile device temporarily implanted into the sinus to maintain an opening and prevent obstruction. It is used for the local moistening of the sinuses through delivery of a selected fluid (e.g., saline or a drug) to treat sinusitis. It is typically designed as a microflow catheter with a micropore reservoir at the distal end which gradually releases the fluid. The implantation procedure is assisted through fluoroscopy or endoscopy. A disposable sinus spacer deployment device will typically be included. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Package | 34063107102159 | GS1 | Carton | 1 | In Commercial Distribution | |
| Primary | 14063107102155 | GS1 |
Customer Contacts
- Phone
- 1-800-433-2674
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K922902 | 000 |
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep dry
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight