FDA UDI
Not in Commercial Distribution
🇺🇸 United States
NA
DI: 10888551040372
·
Model: SCI04526-01
·
STERILMED, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- NA
- Primary DI
- 10888551040372
- Version / Model
- SCI04526-01
- Catalog Number
- SCI04526-01
- Company Name
- STERILMED, INC.
- Labeler DUNS
- 175899459
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-22
- Public Version
- 6
- Public Version Date
- 2020-05-06
- Public Version Status
- Update
- Public Device Record Key
- 054a8786-2bd1-4217-bf86-5ed3aa009c7c
- Distribution End Date
- 2019-04-17
Device Description
BALLOON INFLATION DEVICE ENCORE 26
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
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- 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
- Yes
- Sterilization Methods
- Ethylene Oxide
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| NKU | INJECTOR AND SYRINGE, ANGIOGRAPHIC, BALLOON INFLATION, REPROCESSED | Cardiovascular | 870.1650 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 46633 | Catheter/overtube balloon inflator, reprocessed | A device designed to inflate and regulate the pressure of the balloon of a catheter, endoscopic overtube, or other invasive device (e.g., tamp, endomicroscopy probe), typically by injecting and aspirating fluid or air within the balloon, and to deflate the balloon during a medical procedure. It typically consists of a dedicated manual syringe/plunger or electronic mechanism for inflation/deflation, an analogue or digital gauge/screen for monitoring pressure, a locking mechanism, and a connecting tube. This is a single-use device that has previously been used on a patient and has been subjected to additional processing and manufacturing for an additional single-use patient application. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 10888551040372 | GS1 |
Customer Contacts
- Phone
- +1(888)541-0078
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K053188 | 000 |