FDA UDI
In Commercial Distribution
🇺🇸 United States
GORE® Tri-Lobe Balloon Catheter
DI: 00733132619849
·
Model: TBCM1634
·
W. L. Gore & Associates, Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- GORE® Tri-Lobe Balloon Catheter
- Primary DI
- 00733132619849
- Version / Model
- TBCM1634
- Catalog Number
- TBCM1634
- Company Name
- W. L. Gore & Associates, Inc.
- Labeler DUNS
- 967358115
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-06-11
- Public Version
- 1
- Public Version Date
- 2025-06-19
- Public Version Status
- New
- Public Device Record Key
- 3406f2d9-775f-4b24-bb83-ac5d725c8410
Device Description
TRI-LOBE BALLOON CATHETER 18Fr
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
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 00733132619849 | GS1 |
Customer Contacts
- Phone
- +1(800)528-8763
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K250410 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Length | 104 | Centimeter | |
| Catheter Gauge | 18 | French | |
| Length | 108 | Millimeter |