FDA UDI
In Commercial Distribution
🇺🇸 United States
SAT CenterFlow Molding Balloon Catheter
DI: 06009880940004
·
Model: IN20-00313
·
STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- SAT CenterFlow Molding Balloon Catheter
- Primary DI
- 06009880940004
- Version / Model
- IN20-00313
- Catalog Number
- IN20-00313
- Company Name
- STRAIT ACCESS TECHNOLOGIES HOLDINGS (PTY) LTD
- Labeler DUNS
- 539063485
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-12-01
- Public Version
- 2
- Public Version Date
- 2025-12-16
- Public Version Status
- Update
- Public Device Record Key
- a952731c-1d01-4b8d-83c8-769ef3f71b31
- Distribution End Date
- 2026-09-22
Device Description
The SAT CenterFlow Molding Balloon Catheter is intended to assist in the dilatation of self-expanding endoprostheses in large diameter vessels. Introducer sheath compatible, 18 Fr.
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
- Yes
- 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 |
|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 66384 | Aortic endovascular implant post-dilation balloon catheter | A flexible tube or shaft with an inflatable balloon(s) at its distal end intended for percutaneous introduction to dilate and stabilize within the aorta a previously deployed aortic endovascular implant (e.g., stent-graft) [not included]; it is not intended for vessel occlusion. It typically includes a guidewire, inflation port, and haemostasis valve. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 06009880940004 | GS1 |